Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755673
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2021-02-02
Brief Title:
Atrantil for Intestinal Bacterial Overgrowth
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Open-Label Assessment of the Efficacy of Atrantil In the Treatment of Methane-Predominate Intestinal Bacterial Overgrowth
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None