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

When bacteria normally found in the large intestine become present in the small intestine, the digestive system may produce excessive hydrogen and/or methane gas, which can cause many gastrointestinal symptoms such as bloating, diarrhea, and/or constipation. This condition has historically been diagnosed as Small Intestinal Bacterial Overgrowth (SIBO) and either classified as hydrogen-related SIBO or methane-related SIBO. However, new guidelines outlining the distinction between each classification has led to the reclassification of methane-related SIBO as Intestinal Methanogen Overgrowth (IMO), since methane in the gastrointestinal tract is produced by archaea, which is actually not a bacteria.

The Hydrogen and Methane Breath Test for SIBO & IMO can be ordered with either a lactulose or glucose substrate. Pediatric kits are also available.

Taking the SIBO & IMO 10 Tube Breath Test

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Substrate packet (either glucose or lactulose)

(10) Collection tubes in a vacuum-sealed pack

(1) Sample label card with 10 labels

(1) Prepaid return shipping label

(1) 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.

Preparing for Sample Collection

Patients should consult with their healthcare provider prior to taking this test. It is okay to drink water while fasting and during the 2-hour and 15-minute testing period. If you are taking more than one breath test, you must perform the preparation prior to each test.

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 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

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).

  • Start 12-hour diet at 7am
  • Start 12-hour fast at 7pm
  • Wake up at 6am
  • Start performing sample collection at 7am

12-Hour Diet:

Only the foods listed below are permitted during the diet:

  • Baked or Broiled: chicken, turkey, lean beef, lean pork, or seafood
  • Eggs
  • White rice
  • Water, plain coffee, or tea
  • Minimal fats and seasoning (i.e. salt, pepper, cooking oil)

12-Hour Fasting Period:

Please do not ingest anything other than water while fasting or during the test. You may brush your teeth as you normally would. Please note that you must be awake for at least 1 hour prior to starting your breath test.

Performing Sample Collection

Carefully open the substrate and mix the substrate with 8oz of room temperature water.

DO NOT DRINK YET.

Once collected, your breath samples are only valid for 2 weeks so please return your completed samples back as soon as possible.

Collecting Your Sample
  1. Carefully open the sealed pack of collection tubes using a pair of scissors.
  2. Unscrew the blue cap from a collection tube.
  3. Unwrap the collection straw and insert the straw about halfway into the tube.
  4. Inhale normally (do not inhale deeply) and then exhale normally through the straw for 5 seconds. You may see condensation on the inside of the tube indicating the presence of your breath.
  5. Remove the straw and immediately screw the blue cap back on the top of the tube securely but do not over-tighten. The blue cap has a rubber piece which is for laboratory extracting purposes only; it is not for patient use.
  6. Complete and apply the included sample labels with your full name, date of birth, and the date and time the sample was collected.
  7. Fully complete the Laboratory Requisition Form by filling in the patient information as well as the insurance/credit card information. Please note if your kit was directly shipped to you, CDI has your provider’s signature and information on file and it does not need to be included on the Laboratory Requisition Form.
Returning Your Sample

After completing your test, place all the labeled collection tubes into the provided bubble bags. Place the filled bubble bags and your completed Laboratory Requisition Form into the kit box, then seal the kit box with the prepaid return shipping label.

You can either take your kit to the nearest drop box or arrange to have your kit picked up by the carrier on the return shipping label.

If there are any issues with your kit, or any of its components, contact CDI with your kit’s unique number for assistance. The number is printed on the side of the kit box next to the “SN” symbol.

PAYMENT GUIDELINES: Prior to returning your test kit, please review the test payment guidelines that are included on the Laboratory Requisition Form. For a list of in-network insurance carriers visit www.commdx.com/insurance.

CDI will submit a claim on the patient’s behalf to commercial insurance, Medicare or Tricare. Insurance may cover some or all of the test depending on the patient’s insurance plan and benefits. In the event the patient’s insurance provider denies the insurance claim, or if the patient has not met the deductible or has a coinsurance or co-pay, or if for any reason the insurance does not cover the full amount of the test, the patient is responsible to pay CDI for products and services received.

CDI does not accept any Medicaid plans: therefore any Medicaid patient taking a test will be responsible for the full cost of the test. CDI offers convenient payment plans and financial hardship programs for qualifying patients. Patients may pay up front via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $175 for patients that pay promptly in accordance with CDI patient billing policies and programs. For an updated list of in-network providers, please visit www.commdx.com/insurance.

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: 82542 x 6 units
  • Tax ID #: 47-4725769
  • NPI #: 1831625342

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).

Contraindications: Patients with a known lactulose allergy should not take this test using a lactulose substrate. Patients with a low galactose diet should discuss with their healthcare provider prior to taking this test. Patients with diabetes should not use this test due to the amount of absorbable sugar and fasting required. Patients should discuss with their healthcare provider prior to ingesting the substrate.

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, or throat.

What’s in the Kit?

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Substrate packet (either glucose or lactulose)

(10) Collection tubes in a vacuum-sealed pack

(1) Sample label card with 10 labels

(1) Prepaid return shipping label

(1) 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.

Preparing for Sample Collection

Patients should consult with their healthcare provider prior to taking this test. It is okay to drink water while fasting and during the 2-hour and 15-minute testing period. If you are taking more than one breath test, you must perform the preparation prior to each test.

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 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

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).

  • Start 12-hour diet at 7am
  • Start 12-hour fast at 7pm
  • Wake up at 6am
  • Start performing sample collection at 7am

12-Hour Diet:

Only the foods listed below are permitted during the diet:

  • Baked or Broiled: chicken, turkey, lean beef, lean pork, or seafood
  • Eggs
  • White rice
  • Water, plain coffee, or tea
  • Minimal fats and seasoning (i.e. salt, pepper, cooking oil)

12-Hour Fasting Period:

Please do not ingest anything other than water while fasting or during the test. You may brush your teeth as you normally would. Please note that you must be awake for at least 1 hour prior to starting your breath test.

Performing Sample Collection

Carefully open the substrate and mix the substrate with 8oz of room temperature water.

DO NOT DRINK YET.

Once collected, your breath samples are only valid for 2 weeks so please return your completed samples back as soon as possible.

Collecting Your Sample
  1. Carefully open the sealed pack of collection tubes using a pair of scissors.
  2. Unscrew the blue cap from a collection tube.
  3. Unwrap the collection straw and insert the straw about halfway into the tube.
  4. Inhale normally (do not inhale deeply) and then exhale normally through the straw for 5 seconds. You may see condensation on the inside of the tube indicating the presence of your breath.
  5. Remove the straw and immediately screw the blue cap back on the top of the tube securely but do not over-tighten. The blue cap has a rubber piece which is for laboratory extracting purposes only; it is not for patient use.
  6. Complete and apply the included sample labels with your full name, date of birth, and the date and time the sample was collected.
  7. Fully complete the Laboratory Requisition Form by filling in the patient information as well as the insurance/credit card information. Please note if your kit was directly shipped to you, CDI has your provider’s signature and information on file and it does not need to be included on the Laboratory Requisition Form.
Returning Your Sample

After completing your test, place all the labeled collection tubes into the provided bubble bags. Place the filled bubble bags and your completed Laboratory Requisition Form into the kit box, then seal the kit box with the prepaid return shipping label.

You can either take your kit to the nearest drop box or arrange to have your kit picked up by the carrier on the return shipping label.

If there are any issues with your kit, or any of its components, contact CDI with your kit’s unique number for assistance. The number is printed on the side of the kit box next to the “SN” symbol.

PAYMENT GUIDELINES: Prior to returning your test kit, please review the test payment guidelines that are included on the Laboratory Requisition Form. For a list of in-network insurance carriers visit www.commdx.com/insurance.

Billing & Insurance

CDI will submit a claim on the patient’s behalf to commercial insurance, Medicare or Tricare. Insurance may cover some or all of the test depending on the patient’s insurance plan and benefits. In the event the patient’s insurance provider denies the insurance claim, or if the patient has not met the deductible or has a coinsurance or co-pay, or if for any reason the insurance does not cover the full amount of the test, the patient is responsible to pay CDI for products and services received.

CDI does not accept any Medicaid plans: therefore any Medicaid patient taking a test will be responsible for the full cost of the test. CDI offers convenient payment plans and financial hardship programs for qualifying patients. Patients may pay up front via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $175 for patients that pay promptly in accordance with CDI patient billing policies and programs. For an updated list of in-network providers, please visit www.commdx.com/insurance.

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: 82542 x 6 units
  • Tax ID #: 47-4725769
  • NPI #: 1831625342
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).

Contraindications: Patients with a known lactulose allergy should not take this test using a lactulose substrate. Patients with a low galactose diet should discuss with their healthcare provider prior to taking this test. Patients with diabetes should not use this test due to the amount of absorbable sugar and fasting required. Patients should discuss with their healthcare provider prior to ingesting the substrate.

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, or throat.

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Frequently Asked Questions

Here is a list of the most common questions regarding our 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 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 a hydrogen and methane breath test for small intestinal bacterial overgrowth?

The Hydrogen and Methane Breath Test for SIBO 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, 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 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. Our SIBO breath test 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).