Patient Resources

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 bacteria naturally exist throughout the digestive tract, with the 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 material 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, and some researchers even hypothesize a connection between SIBO and common skin disorders like acne and rosacea.

Intestinal Methanogen Overgrowth (IMO), formally called methane-dominate SIBO (Small Intestinal Bacterial Overgrowth), is characterized by an excessive population of methane-producing archaea in the intestines. It has been increasingly recognized for its implications for gastrointestinal (GI) health and its association with conditions like Irritable Bowel Syndrome (IBS), particularly the constipation-predominant type (IBS-C). Hydrogen and methane breath testing has emerged as a critical tool in diagnosing IMO, providing valuable insights that guide the clinical management of affected patients. (text taken from The IMO Landscape: Insights from Breath Testing Research and Clinical Practice | Commonwealth Diagnostics International)

Hydrogen and methane breath testing is based on the concept that bacteria can enter and proliferate in the small intestine and produce trace gases that are not generated by any normal function in the human body. By measuring the levels of these trace gases (hydrogen and methane) in the breath using gas chromatography, the test can aid in the diagnosis of small intestinal bacterial overgrowth (SIBO) and other gastrointestinal disorders like sugar malabsorption

• Scan the QR code on the inner box label or follow the link here: Register Kit
  • Step 1: On the first screen, enter the barcode number of your test kit (DX followed by 6 digits) into the top box. In the second box enter the “unique code” on your inner box label, just under the QR code. In the bottom box enter the generated text code above it. Then click “Validate”.
  • Step 2: Enter your information in the labeled boxes.
    • For the Date of Birth, you can either type the date as MM/DD/YYYY in the box or click the calendar icon. To change the year in the calendar pop-up, click on it, scroll back to the correct year, select it, then select the correct month from the list, then the day.
  • Step 3: Respond to how you received your kit and how you would like it billed. If you select “I would like CDI to submit a claim to my insurance,” the next page will ask for your insurance details and to upload images of your card(s). If you select, “I elect to self-pay the maximum out-of-pocket cost,” this will be your last screen.
  • Step 4: If you selected “I would like CDI to submit a claim to my insurance,” you will be prompted to enter your insurance details and upload images. The images have a maximum file size, and the boxes will turn red if the file exceeds that limit. If this occurs, attempt to resave the file in a different format (like jpeg) or to compress the file first.
• If you have any issues, please contact our customer service team at customerservice@commdx.com. Kit registration streamlines the data entry process. Though this is a useful tool to ensure the correct insurance and other details are received, it is not required if your requisition form is completed correctly.

We provide a pre-paid, pre-addressed shipping label in each kit. Patients will simply return their completed samples, now in bubble wrap, to the original kit box, sealing the test kit with the provided shipping label, and return it to us using the carrier service specified on the return label.

When the kit arrives at our laboratory, it will be analyzed within 1 business day. Kits that arrive on weekends or Holidays will be analyzed the following business day. Results will be sent to your provider’s office via a secure fax system, secure email, or secure provider portal.

Results will be sent to your provider within 24-48 hours of receiving your test kit at our laboratory. You may request a copy directly, available upon completion of a HIPAA release form.

CDI may not know that a test is invalid until it is fully processed by the lab. Failure to follow the Instructions For Use located in each patient’s test kit can lead to an invalid test result.  Patients may still be billed for the test if the test is invalid, rejected, or expired, but may receive a complimentary retest with no out-of-pocket cost if requested within 90 days of the release of results.

An invalid breath test means that CDI was not able to provide a valid result. Here is a list of reasons why your determination may be invalid:

• The breath test arrived after the three-week viability
• Invalid Baseline Sample (see next FAQ for additional information)
• Incorrect Collection Timing Intervals
• Invalid Samples
• No Labels on Test Tubes
• Test Kit Expired
• Non-CDI Kit Components were Used
• The substrate was not ingested at the correct time.
• The samples were collected across multiple days.
• Multiple Damaged Septa

Please note that the specific reason for an invalid result is provided in the report along with additional details. Please contact your provider for more information. CDI will bill patients when the result is an “Invalid” due to poor patient prep, patient misuse, using an expired kit, providing the incorrect sample type, or other failures to comply with Instructions for Use. In that scenario, however, CDI also offers those patients a complimentary second test, if the patient completes payment for their original test, when requested within 90 days.

Invalid baselines are caused by the patient not taking a proper sample for the first tube. CDI may not know that a test is invalid until it is fully processed by the lab.  Patients may still be billed for the test if the test is invalid due to patient error.  As all of our results are based on the baseline sample, and we follow the North American Consensus on Breath Testing, CDI is not able to provide a valid result when the baseline sample is not collected properly.  Additional information is provided on your result report provided to your doctor that explains how your provider can use the results to help either form an interpretation or recommend retesting.

CDI will bill patients when the result is an “Invalid” due to an invalid baseline sample, however, CDI also offers patients a complimentary second test, if the patient completes payment for their original test, when requested within 90 days.

CDI offers interpretation assistance to providers only for all of our diagnostic test kits. Please contact your provider for information relating to your results.  Please note that CDI can only discuss the following with your provider:  parameters of our test, test methods, most common results and instrumentation questions.  Patient symptoms may vary, so it’s important to discuss your symptoms and correlations with your provider directly.  You can find an explanation of the 6 most common results for hydrogen & methane breath tests here. CDI follows guidance from the North American Consensus on Breath Testing for all of our hydrogen & methane breath tests.  A summary of the consensus can be found here, and the full consensus from the American Journal of Gastroenterology can be found here.

Only the following foods are permitted during the 12-hour preparatory diet period:

• Olive Oil, Salt, & Pepper (minimal seasonings)
  • CDI recommends a maximum of 1 Tbsp. of Cooking oil per meal and a maximum of 3 Tbsp. for the entire 12-hour restricted diet.
• Plain Black Coffee, Plain Black or Green Tea (no herbal teas)
  • No sweeteners, creamers, flavorings, etc. may be added to any of the beverages or food items listed above.
• Plain, Still Water
• Plain White Bread
• Eggs
• Plain Tofu
• Baked or Broiled Seafood, Lean Beef, Lean Pork, Chicken, & Turkey (no deli meat)
  • Any lean cut of meat (including goat, lamb, etc) may be consumed in addition to those listed above.
• White Rice
• Boiled or Mashed Potatoes, Carrots, and Turnips, without skin

NOTE: All other foods not listed above are not allowed during the 12-hour preparatory diet. Foods such as, but not limited to: alcohol, dairy, beans, wheat, grains, fruits and vegetables, and high-fiber containing foods are not allowed. Be sure to consult the Instructions for Use included in your kit and additional information here: CDI Updates Instructions for Use (IFUs) with Expanded Permitted Foods List.

Yes. A 12-hour fast is required prior to all breath tests. Water can be consumed during this time and during the test.

Yes, the preparation period requires several activity restrictions:

• Patients should be awake and upright for at least 1 hour prior to taking the test and should not sleep at any time during the test.
• Patients should not perform any exercise the day of the test until sample collection has been completed.

Yes, the preparation period requires several medication restrictions:

• Patients must wait four weeks after the last dose of any ingested or injected antibiotic, even short regimens or individual doses taken prophylactically.
• Patients will need to refrain from any laxative or pro-motility (aids in production of bowel movements) medications, OTCs, or supplements for four weeks prior to testing as well. This includes fiber & herbal supplements, Magnesium citrate and any magnesium blend used for promotility effects, digestive enzymes, or similar. Please review any medications or supplements you are unsure of with a physician.
• Probiotics do not have the same restrictive timeframe and only need to be stopped during the 24-hour preparation period and test day. Pre-biotics are fiber supplements and do fall under the week restriction.
• We do NOT have a restriction on PPIs, H2 Blockers, and other acid maintenance medications.

Patients should not smoke or vape any substance for at least 24 hours prior to testing and not during the testing timeframe. Smoking and vaping can increase CO2 in your system and invalidate your test.

For Nicotine users, a patch is recommended. Nicotine Gum is not allowed during the preparation period or test day due to the potential effect of sweeteners on the test.

For THC users, tincture drops are allowed. Patients should not consume any edibles or infused beverages due to the dietary restrictions required for the preparation and test.

If you remembered to collect the baseline sample within 15 minutes of consuming the substrate, the test can be continued as normal. Be sure to collect the second sample 15 minutes after consuming the substrate. If the baseline sample was collected after 15 minutes, the test needs to be repeated.

If the event was within 15-30 minutes after consuming the substrate, the test needs to be repeated. If the event was more than 30 minutes after consuming the substrate, the test can be continued as normal.

Yes, you must drink the entire substrate mixture, quickly, for the test to be valid. If you do not drink the entire mixture, the test must be repeated.

No. Eating at any point during the test will make the test results invalid. The test must be repeated.

If either the times or sample numbers were recorded, then we can process your test. If you do not record the time of the sample, we will include a note to your health care provider with your test results. Your health care provider will determine whether to accept the test results that were not labeled with times for each sample. If neither the time nor sample numbers were recorded, the test will not be analyzed.

If you need a replacement test kit due to an error in testing, missing components, etc, and a kit was mailed to your home by CDI, please contact our Customer Service team to request a reshipment. If the kit was provided to you in your physician’s office, please contact them for a replacement.

If you received an Invalid, Rejected, or Expired test result report, please contact our Customer Service team to request a complimentary retest kit within 90 days of receiving the initial result.

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).

Lactulose is a synthetic sugar solution, used as a prescribed laxative. The liquid lactulose substrate is provided in a small cup included in the kit.

• In the United States, lactulose contains a 10-gram dose of lactulose with less than 1.6-grams of galactose, less than 1.2-grams of lactose, and 1.2- grams of other sugars. If you have a sensitivity to any of the sugars listed, please consult your healthcare provider/nutritionist for a possible alternative substrate they can prescribe. (i.e. glucose)
• Outside the United States, lactulose contains a 10-gram dose of lactulose with more than 5-grams of lactose/galactose/epilactose. If you have a sensitivity to any of the sugars listed, please consult your healthcare provider/nutritionist for a possible alternative substrate they can prescribe. (i.e. glucose)

Glucose is 100% glucose (dextrose) sugar provided in powder form in the amount of 75g. If you are sensitive and/or have diabetes (Type I or II), please consult with your healthcare provider if this substrate is right for you. (This substrate may be derived from corn.)

Fructose is 100% fructose sugar, provided in powder form in the amount of 25g.

Lactose is 100% lactose sugar, provided in powder form in the amount of 25g.

Sucrose is 100% sucrose sugar, provided in powder form in the amount of 50g.

Your breath samples are stable for up to three weeks and across a wide temperature range (-4°F to 104°F). Samples received after three weeks of collection will be invalid.

We consider any samples with a Carbon Dioxide (CO2) concentration of less than 2.00% to be an invalid sample as this falls outside of the normal range in human breath.

If there are any components missing from any test kit, we will send out replacement component(s) or a new test kit to you or health care provider. Please contact our Customer Service Department at 1-888-258-5966 in this instance.

If you have to multiple test kits to perform, you may not take more than one per day. Please wait at least 24 hours between taking each test, though you may wait longer. The full 24-hour preparatory period, 12 hours of following the restricted diet followed by twelve hours of fasting, must be adhered to before each test.

Please be sure to keep each test kit’s paperwork and components with the box they arrived in, matching the barcode number on the requisition form to the barcode number on the outside of the box. When performing multiple tests, double check that the correct substrate is being ingested and the correct number of samples collected for the test type listed on your kit box and Instructions For Use.

For any patient that has tested positive for COVID-19, CDI has adopted a corporate policy whereby you should not administer and return your test kit, and CDI will not accept samples from any known COVID-19 positive patient, until thirty days (30) have passed following a negative follow-up test for COVID-19 from your healthcare provider.

We are implementing this policy in an abundance of caution in order to provide for the safest possible environment for our patients as well as our employees and clinical staff. We thank you for your cooperation with our policies, we wish you a speedy recovery and good health, and we look forward to working with you in the near future to help diagnose your gastrointestinal symptoms.