Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bacterial Overgrowth Syndrome
  • Irritable Bowel Syndrome
  • SIBO
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: All participants receive 4 weeks (28 days)supply of Atrantil- 2 capsules 3 times per day .Masking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Intestinal microbial overgrowth is associated with multiple gastrointestinal symptoms. Most prevalent are gas-related symptoms (i.e. bloating, distention, increased flatus, constipation) . Intestinal microbial overgrowth can currently be divided into two main subcategories: small intestinal bacteria...

Intestinal microbial overgrowth is associated with multiple gastrointestinal symptoms. Most prevalent are gas-related symptoms (i.e. bloating, distention, increased flatus, constipation) . Intestinal microbial overgrowth can currently be divided into two main subcategories: small intestinal bacterial overgrowth (SIBO) and intestinal methanogenic overgrowth (IMO). Both are most commonly detected via breath testing-a simple non-invasive study Despite the increasing prevalence of this disorder few evidence-based therapeutics currently exist. SIBO, identified by elevations in breath hydrogen, has been shown to respond to treatment with antibiotics including rifaximin and doxycycline in clinical trials However, IMO, detected by elevations in breath methane is a different disorder attributed to overgrowth of archaea which reside predominately in the colon Currently, there are no evidence-based treatments for IMO, and the American College of Gastroenterology guideline on the diagnosis and treatment of SIBO makes no specific recommendations regarding the treatment of this disorder. Atrantil is a medical food composed of peppermint, quebracho tree bark, and horse chestnut. These components are purported to reduce methane production, scavenge hydrogen (thus reducing the building blocks for methane), and potentially act as a cidal agent for methanogenic archaea. In a small randomized controlled-trial, Atrantil reduced bloating and constipation in a population of individuals with irritable bowel syndrome with constipation (IBS-C) Given these initial results the investigators hypothesize that Atrantil may represent an inexpensive and safe treatment for patients with excessive methane production. Thus, the purpose of this study is to determine whether the holistic treatment, Atrantil, is beneficial for the treatment of IMO.

Tracking Information

NCT #
NCT04755673
Collaborators
Not Provided
Investigators
Principal Investigator: Darren Brenner, MD Northwestern Memorial Hospital/Feinberg School of Medicine