This breath test aids in the diagnosis of Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogen Overgrowth (IMO) for pediatric patients.

The Hydrogen and Methane 6 Tube Lactulose Breath Test for SIBO & IMO offers a comprehensive, non-invasive diagnostic solution tailored specifically for pediatric patients. With a focus on accuracy, comfort, and convenience, our pediatric breath test provides crucial insights into functional GI disorders, supporting effective treatment plans.

CDI’s pediatric breath test, validated by rigorous research, can help identify Small Intestinal Bacterial Overgrowth (SIBO) and Intestinal Methanogen Overgrowth (IMO) in young patients, ensuring they receive the targeted care they need for better gastrointestinal health.

The SIBO & IMO 6 Tube Lactulose Hydrogen & Methane Breath Test Collection Kit is for pediatric patients only. Pediatric patients may also utilize CDI’s breath tests for the diagnosis of carbohydrate malabsorption from fructose, sucrose, and/or lactose.

Taking the SIBO & IMO 6 Tube Breath Test (for Pediatrics Only)

Your SIBO & IMO 6 Tube Kit Includes:

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Substrate packet (either glucose or lactulose)

(6) Collection tubes in a vacuum-sealed pack

(1) Sample label card with 6 labels

(1) Prepaid return shipping label

(2) Bubble wrap bags for packaging of samples

Patients should follow the Instructions for Use in their kit for additional test instructions and updated return shipping information. Patients can also contact CDI’s dedicated customer service team at 888-258-5966 or customerservice@commdx.com with questions or concerns.

Important Reminders
  1. Be sure to check the expiration date of your test kit which is located on the outside of your kit next to the hourglass image displayed as YEAR/MONTH/DAY. Do not take your test if the expiration date has already passed and reach out to CDI to receive a new test kit.
  2. Samples are valid for two [2] weeks from sample collection and must be received at CDI’s lab within this timeframe. Please ship your kit back to CDI immediately after completing the test.
  3. Failure to follow these instructions can lead to an invalid result. You may still be billed for the test if the test is invalid due to patient error.
  4. Please be sure to thoroughly read the billing & insurance policies in these instructions as well as on your requisition form. Additional information can be found here on our website, www.commdx.com/insurance.
  5. If you have multiple test kits, please keep in mind that the full 24-hour preparation will need to be repeated between each test. We recommend spacing test apart by at least 24 hours.
Test Preparation

TEST RESTRICTIONS

  • Discontinue the use of any antibiotics for 4 weeks prior to taking the test.
  • Discontinue the use of any laxatives and/or promotility drugs (i.e. anything that helps aid in the movement of your bowels) for 1 week prior to taking the test.
  • Do not smoke or vape for at least 24 hours prior to the test, or any time during the test.
  • Do not sleep or exercise for at least 1 hour prior to taking the test or at any time during the test.

24 HOUR PREPARATION PERIOD

SUGGESTED SCHEDULE:

It may be convenient to begin the 24-hour preparation period in the morning so that you may follow the specific diet during the day, immediately followed by the fasting period during the night (which may include time spent sleeping).

12-HOUR DIET: PERMITTED FOODS ONLY

12-HOUR FASTING PERIOD

  • Do not ingest anything other than water while fasting or during the test.
  • You may take necessary prescribed medications cleared by your physician
  • Do not take any vitamins or supplements.
  • You may brush your teeth as you normally would.
  • You must be awake for at least 1 hour prior to starting the test.
8 Simple Steps for SIBO & IMO 10 Tube Breath Test

Please read carefully prior to taking your breath test:

  • CDI will submit a claim on your behalf for all commercial insurance plans. Most commercial insurance plans do not consider CDI as an in-network provider, therefore most patients will be responsible for the maximum out-of-pocket cost of $249 per breath test.
  • If your insurance provider is not listed on our website as an in-network provider, your claim will be billed as an out-of-network claim. It is the patient’s responsibility to contact their insurance provider to determine coverage. CPT codes and other information needed to determine coverage can be found on our website. Please note, our lab is separate from your healthcare provider, so if your healthcare provider is in-network, it does not mean that CDI is in-network. Please refer to our website for a list of in-network insurance providers.
  • CDI accepts all Medicare, Medicare Advantage, and Tricare government managed health insurance plans.
  • CDI does not accept Medicaid. If you are a Medicaid patient, you will be billed for the maximum out-of-pocket
    cost of $249 per breath test.
  • CDI offers convenient payment plans and financial hardship programs for those who qualify. Contact CDI’s customer service team at customerservice@commdx.com or visit our website for more information.
  • Insurance payments are applied to the registered cost of our test, $599. All non-covered costs are the patient’s responsibility. The maximum out-of-pocket cost will not exceed $249 per test.

If you wish to see how much your insurance provider will cover before you take your test, it is your responsibility to contact your insurance provider. Please make sure to inform your insurance provider CDI is out of network and provide the following codes:

  • CPT code: 91065 x 2 units
  • Tax ID #: 47-4725769
  • NPI #: 1831625342

Visit www.commdx.com/insurance for important information including a list of our in-network providers and billing & insurance FAQs.

Indications and Usage: The intended use of this device is for the collection of human breath samples to aid in the diagnosis of Small Intestinal Bacterial Overgrowth (SIBO) or Intestinal Methanogen Overgrowth (IMO).

Contraindications: Patients with a known lactulose allergy should not take this test. Patients with a low galactose diet should discuss with their healthcare provider prior to taking this test. Although lactulose is a non-absorbable synthetic sugar, patients with diabetes should consult with their healthcare provider prior to taking the test due to the fasting period required and any other impact the test may have on blood sugar levels.

Precautions: Patients with food allergies should take precaution before taking this test as most substrates do not come with food allergy labeling. Contact immediate medical assistance if you have signs of a possible allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, and throat. Any serious incident that occurs in relation to this device shall be reported to the manufacturer and the competent authority of the member state in which the patient is established.

Please consult with your healthcare provider if you have any health concerns, are on a specialty diet, and/or are on prescribed medications. Please do not discontinue taking any prescribed or over-the-counter (OTC) medications, including the ones listed in the Test Restrictions section, without consulting with your healthcare provider prior to taking this test.

Lactulose Substrate manufacturer’s information*
Store at 20°-25°C (68°-77°F). Avoid subfreezing temperatures. Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.

* The lactulose substrate is provided “as is” and CDI makes no representations or warranties whatsoever, express or implied, including without limitation any implied warranty of merchantability or fitness for a particular purpose. Patients should consult with their healthcare provider before ingesting this substrate.

What’s in the Kit?

Your SIBO & IMO 6 Tube Kit Includes:

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Substrate packet (either glucose or lactulose)

(6) Collection tubes in a vacuum-sealed pack

(1) Sample label card with 6 labels

(1) Prepaid return shipping label

(2) Bubble wrap bags for packaging of samples

Instructions for Use

Patients should follow the Instructions for Use in their kit for additional test instructions and updated return shipping information. Patients can also contact CDI’s dedicated customer service team at 888-258-5966 or customerservice@commdx.com with questions or concerns.

Important Reminders
  1. Be sure to check the expiration date of your test kit which is located on the outside of your kit next to the hourglass image displayed as YEAR/MONTH/DAY. Do not take your test if the expiration date has already passed and reach out to CDI to receive a new test kit.
  2. Samples are valid for two [2] weeks from sample collection and must be received at CDI’s lab within this timeframe. Please ship your kit back to CDI immediately after completing the test.
  3. Failure to follow these instructions can lead to an invalid result. You may still be billed for the test if the test is invalid due to patient error.
  4. Please be sure to thoroughly read the billing & insurance policies in these instructions as well as on your requisition form. Additional information can be found here on our website, www.commdx.com/insurance.
  5. If you have multiple test kits, please keep in mind that the full 24-hour preparation will need to be repeated between each test. We recommend spacing test apart by at least 24 hours.
Test Preparation

TEST RESTRICTIONS

  • Discontinue the use of any antibiotics for 4 weeks prior to taking the test.
  • Discontinue the use of any laxatives and/or promotility drugs (i.e. anything that helps aid in the movement of your bowels) for 1 week prior to taking the test.
  • Do not smoke or vape for at least 24 hours prior to the test, or any time during the test.
  • Do not sleep or exercise for at least 1 hour prior to taking the test or at any time during the test.

24 HOUR PREPARATION PERIOD

SUGGESTED SCHEDULE:

It may be convenient to begin the 24-hour preparation period in the morning so that you may follow the specific diet during the day, immediately followed by the fasting period during the night (which may include time spent sleeping).

12-HOUR DIET: PERMITTED FOODS ONLY

12-HOUR FASTING PERIOD

  • Do not ingest anything other than water while fasting or during the test.
  • You may take necessary prescribed medications cleared by your physician
  • Do not take any vitamins or supplements.
  • You may brush your teeth as you normally would.
  • You must be awake for at least 1 hour prior to starting the test.
8 Simple Steps for SIBO & IMO 10 Tube Breath Test

Billing & Insurance

Please read carefully prior to taking your breath test:

  • CDI will submit a claim on your behalf for all commercial insurance plans. Most commercial insurance plans do not consider CDI as an in-network provider, therefore most patients will be responsible for the maximum out-of-pocket cost of $249 per breath test.
  • If your insurance provider is not listed on our website as an in-network provider, your claim will be billed as an out-of-network claim. It is the patient’s responsibility to contact their insurance provider to determine coverage. CPT codes and other information needed to determine coverage can be found on our website. Please note, our lab is separate from your healthcare provider, so if your healthcare provider is in-network, it does not mean that CDI is in-network. Please refer to our website for a list of in-network insurance providers.
  • CDI accepts all Medicare, Medicare Advantage, and Tricare government managed health insurance plans.
  • CDI does not accept Medicaid. If you are a Medicaid patient, you will be billed for the maximum out-of-pocket
    cost of $249 per breath test.
  • CDI offers convenient payment plans and financial hardship programs for those who qualify. Contact CDI’s customer service team at customerservice@commdx.com or visit our website for more information.
  • Insurance payments are applied to the registered cost of our test, $599. All non-covered costs are the patient’s responsibility. The maximum out-of-pocket cost will not exceed $249 per test.

If you wish to see how much your insurance provider will cover before you take your test, it is your responsibility to contact your insurance provider. Please make sure to inform your insurance provider CDI is out of network and provide the following codes:

  • CPT code: 91065 x 2 units
  • Tax ID #: 47-4725769
  • NPI #: 1831625342

Visit www.commdx.com/insurance for important information including a list of our in-network providers and billing & insurance FAQs.

Additional Info

Indications and Usage: The intended use of this device is for the collection of human breath samples to aid in the diagnosis of Small Intestinal Bacterial Overgrowth (SIBO) or Intestinal Methanogen Overgrowth (IMO).

Contraindications: Patients with a known lactulose allergy should not take this test. Patients with a low galactose diet should discuss with their healthcare provider prior to taking this test. Although lactulose is a non-absorbable synthetic sugar, patients with diabetes should consult with their healthcare provider prior to taking the test due to the fasting period required and any other impact the test may have on blood sugar levels.

Precautions: Patients with food allergies should take precaution before taking this test as most substrates do not come with food allergy labeling. Contact immediate medical assistance if you have signs of a possible allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, and throat. Any serious incident that occurs in relation to this device shall be reported to the manufacturer and the competent authority of the member state in which the patient is established.

Please consult with your healthcare provider if you have any health concerns, are on a specialty diet, and/or are on prescribed medications. Please do not discontinue taking any prescribed or over-the-counter (OTC) medications, including the ones listed in the Test Restrictions section, without consulting with your healthcare provider prior to taking this test.

Lactulose Substrate manufacturer’s information*
Store at 20°-25°C (68°-77°F). Avoid subfreezing temperatures. Under recommended storage conditions, a normal darkening of color may occur. Such darkening is characteristic of sugar solutions and does not affect therapeutic action. Prolonged exposure to temperatures above 86°F (30°C) or to direct light may cause extreme darkening and turbidity which may be pharmaceutically objectionable. If this condition develops, do not use. Prolonged exposure to freezing temperatures may cause change to a semi-solid, too viscous to pour. Viscosity will return to normal upon warming to room temperature.

* The lactulose substrate is provided “as is” and CDI makes no representations or warranties whatsoever, express or implied, including without limitation any implied warranty of merchantability or fitness for a particular purpose. Patients should consult with their healthcare provider before ingesting this substrate.

Get your free eBook on breath testing and COVID-19's impact on functional GI diagnostic plans.

Frequently Asked Questions

Here is a list of the most common questions regarding our IMO & SIBO breath tests. Patients can also contact our dedicated customer service department at 888-258-5966 or customerservice@commdx.com.

What is small intestinal bacterial overgrowth (SIBO)?

SIBO is the accumulation of an excessive amount of gut bacteria in the small intestine (at least 100,000 bacteria per ml of fluid). While bacterium naturally exist throughout the digestive tract, with highest concentrations of bacteria in the colon, a healthy individual should have relatively low levels of bacteria present in the small intestine. Any condition which impairs the normal transit or motion of the small intestine can increase the likelihood of getting SIBO, including lack of adequate stomach acid, damage to the intestine by toxins, or a decrease in the speed at which the small intestine transfers waste to the colon. In the U.S., some research studies have demonstrated that up to 80% of the IBS population, or 36 million individuals, suffer from SIBO.

What is the small bowel?

The small bowel, also known as the small intestine, is the part of the gastrointestinal tract that connects the stomach with the colon. The main purpose of the small intestine is to digest and absorb food into the body. The small intestine is approximately 21 feet in length.

What is Intestinal Methanogen Overgrowth (IMO)?

Breath Testing for SIBOFormally known as Methane SIBO (M-SIBO), Intestinal Methanogen Overgrowth (IMO) is becoming an industry standard term for excessive levels of methane detected during a hydrogen and methane breath test.  There are two main reasons for this change in terminology: 1) methanogens that cause methane gas are technically not bacteria, but are part of the Archaea kingdom, and 2) methanogens typically grow in the colon (large intestine), not the small intestine.

 

Per the American College of Gastroenterology’s (ACG) Clinical Guidelines on SIBO: “Although methane is increasingly important and recognized, it creates a nomenclature problem in the SIBO framework. For methane, a concentration of ≥10 ppm at any point during the test is indicative of methanogen colonization. However, methanogens are not “bacteria” (representing the “B” in SIBO) but belong to the domain Archaea and may also overgrow in the colon and not just the small intestine. As such, we have proposed a new term, intestinal methanogen overgrowth (IMO), for methanogens rather than SIBO (Figure 1b).”

What is a hydrogen and methane breath test for SIBO and IMO?

The Hydrogen and Methane Breath Test for SIBO and IMO is a non-invasive diagnostic tool to identify SIBO and can be administered in the comfort of a patient’s own home. Patients are given a substrate solution to drink, which is a mixture of water and a carbohydrate substrate (lactulose or glucose). After drinking the substrate solution, the patient will collect a series of breath samples by simply breathing into a test tube using a straw. In a healthy individual, one would not expect to see any hydrogen or methane in the breath samples for approximately 90 minutes – 2 hours, the approximate time it would take for the substrate to travel to the small intestine to the colon where, in a healthy system, the substrate would be fed upon by bacteria, thus releasing the hydrogen and methane gas. After ingesting a substrate solution, the patient collects breath samples every 15 minutes over a 2-hour and 15-minute (135 minutes) period. During the hydrogen and methane breath test for SIBO and IMO, the presence of elevated levels of hydrogen or methane gas, or both, identified within 90 minutes of ingesting the substrate solution provides evidence of bacteria or methanogens in the upper region of the digestive tract, i.e. at the level of the small intestine. This excessive build up bacteria is often diagnosed as SIBO while excessive methanogens that cause methane gas is often diagnosed as IMO. Our SIBO and IMO breath test kits can be administered in-office or in the comfort of the patient’s own home.

What is the difference between glucose and lactulose substrates?

Glucose is absorbed by the digestive tract so it will not be able to detect SIBO that is further along in the small intestine (proximal jejunum/ileum). However, because of this, glucose is considered to be more sensitive than lactulose, providing less false positives with colonic bacteria.

Lactulose is not absorbed by the digestive tract and will travel through the entire gastrointestinal tract, ultimately providing a complete depiction of all intestinal segments, including the colon (large intestine).