Herbal capsule Biocidin REMOVE for SIBO in irritable bowel syndrome

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with irritable bowel syndrome (IBS) who also have too many bacteria in the small intestine (SIBO), shown by a breath test.

Age

18 years or older

Sex

All sexes can join.

Disease stage

IBS by Rome IV criteria. A lactulose breath test must show SIBO: hydrogen rising more than 20 parts per million above baseline in the first 90 minutes, and/or methane of 10 parts per million or greater. A "flat line pattern" (gas levels 3 parts per million or less, no spikes) is also accepted.

Earlier treatment

No antibiotics or probiotics within 30 days. No current narcotic use. No chronic steroids or biologics.

Biomarker or test result

Positive lactulose breath test for SIBO, or a flat line pattern on the test.

Main reasons for not taking part

• Negative SIBO breath test at the start
• Restricted diets such as low carbohydrate, gluten-free or low FODMAP
• Celiac disease, inflammatory bowel disease, chronic liver disease or a weak immune system
• Pregnant or breastfeeding
• Insulin-dependent or poorly controlled diabetes (HbA1c greater than 7.0% (53 mmol/mol))

The registry criteria, word for word

What the trial wants to find out

The goal of this clinical trial is to learn if an herbal supplement called Biocidin REMOVE can clear small intestinal bacterial overgrowth (SIBO) in adults with irritable bowel syndrome (IBS). SIBO means there are too many bacteria in the small intestine. It can make IBS symptoms worse.

The 2 groups in the trial

• Biocidin REMOVETreatment being tested

  Participants receive Biocidin REMOVE capsules, a herbal preparation supplied as a 665 mg capsule containing 325 mg of the active proprietary blend. Dosing begins with a 9-day titration, increasing by one capsule every three days: one capsule once daily on Days -9 to -7, one capsule twice daily on Days -6 to -4, and two capsules in the morning with one in the evening on Days -3 to -1. Participants reach the target dose of two capsules twice daily on Day 1 and continue at that dose through Day 28. Capsules are identical in appearance to placebo.

• PlaceboPlacebo, for comparison

  Participants receive matching placebo capsules, identical in appearance to Biocidin REMOVE and containing no active ingredients. Placebo follows the same 9-day titration and dosing schedule as the experimental arm: one capsule once daily on Days -9 to -7, one capsule twice daily on Days -6 to -4, two capsules in the morning with one in the evening on Days -3 to -1, then two capsules twice daily on Days 1 through 28.