Atrantil for Intestinal Bacterial Overgrowth

NCT ID: NCT04755673

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2022-09-27

Brief Summary

Intestinal Bacterial Overgrowth (IBO) is a common functional condition due to excessive amounts of bacteria in the gastrointestinal tract. These bacteria ferment ingested food resulting in the production of hydrogen, methane, and carbon dioxide which subsequently can induce GI symptoms including abdominal pain, bloating, distention, diarrhea and constipation. Typically this condition is treated with antibiotics but for a portion of patients symptoms often recur. Recent work suggests that increased methane production may emanate from overgrowth of a specific type of archaebacteria, causing the aforementioned symptoms. However, no current therapies exist to treat this phenomenon. The investigators propose to trial the supplement Atrantil on patients with IMO in order to study the supplements impact on symptoms, quality of life, and methane levels.

Detailed 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 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.

Conditions

Irritable Bowel Syndrome; Bacterial Overgrowth Syndrome; SIBO

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental: Atrantil (Medical Food)

All participants in the trial will take two capsules of Atrantil three times a day for 28 days.

Group Type: EXPERIMENTAL

Atrantil (Medical Food)

Intervention Type: OTHER

All participants will be given 28 days supply of Atrantil. The impact of the intervention will be measured by daily symptom surveys as well as a hydrogen methane breath test administered at the end of the 28 days of treatment to identify if methane levels have changed.

Interventions

Atrantil (Medical Food)

All participants will be given 28 days supply of Atrantil. The impact of the intervention will be measured by daily symptom surveys as well as a hydrogen methane breath test administered at the end of the 28 days of treatment to identify if methane levels have changed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Participants must be able to provide informed consent

2. Participants must be able to attend study visits

3. Participants aged 18 years or greater

4. Must have a diagnosis of Intestinal Methane Overgrowth based on North American Consensus/American College of Gastroenterology established cutoffs

5. Participants must report current symptoms of bloating, distention, abdominal pain, abdominal discomfort and constipation

6. Participant must be an established patient at Northwestern Memorial Hospital

Exclusion Criteria

1. Participants who are already taking Atrantil

2. Participants who are pregnant or breast-feeding

3. Participants who cannot tolerate or are unwilling to complete a hydrogen-methane breath test at week 4.

4. Inability to attend all study visits and complete survey data.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Darren Brenner

Associate Professor of Medicine and Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Darren Brenner, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Memorial Hospital/Feinberg School of Medicine

Locations

Northwestern Medicine Digestive Health Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00212557

Identifier Type: -

Identifier Source: org_study_id