Atrantil for Intestinal Bacterial Overgrowth

NCT04755673 | Completed

• 1 other identifier: STU00212557
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Bacterial Overgrowth Syndrome; SIBO

Outcome Measures

Primary Outcomes (3)

• Change in clinical symptoms of Intestinal Methane Overgrowth as measured by daily Numeric Rating Scale (NRS) measuring pain, bloating, distention, and discomfort.

  Numeric Rating Scale is a four-item scale measuring the severity of pain, bloating, distention, and discomfort on a scale of 1 to 10 for each measure. Higher scores indicate a higher level of symptom severity. Lower scores indicate a lower level of symptom severity.

  Daily for 28 days

• Change in clinical symptoms of Intestinal Methane Overgrowth as measured by Patient Reported Outcome Measures Information Systems Gastrointestinal Symptoms Scale (PROMIS-GI)

  PROMIS GI Scales is a collection of eight categories of GI-symptoms (Belly pain, Bowel Incontinence, Constipation, Diarrhea, Disrupted Swallowing, Gas and Bloating, Nausea and Vomiting, and Acid reflux) Higher scores indicate a higher level of symptom severity. Lower scores indicate a lower level of symptom severity.

  Change from Baseline at four weeks.

• Change in clinical symptoms of Intestinal Methane Overgrowth as measured by the Bristol Stool Scale (BSS)

  BSS is a clinical tool that divides feces into 7 categories along the continuum severe constipation to severe diarrhea to demonstrate the effectiveness of a treatment

  Change from Baseline at four weeks.

Secondary Outcomes (3)

• Change in quality of life as measured by Short Form- 12.

  Change from Baseline at four weeks.

• Change in Quality of life as measured by the PROMIS-Global Health (PROMIS-GH)

  Change from Baseline at four weeks.

• Change in methane as measured by hydrogen methane breath-test pre and post-treatment.

  Post-Treatment (+-3 days)

Study Arms (1)

Experimental: Atrantil (Medical Food)

EXPERIMENTAL

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

Other: Atrantil (Medical Food)

Interventions

Atrantil (Medical Food) 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.

Experimental: Atrantil (Medical Food)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be able to provide informed consent
• Participants must be able to attend study visits
• Participants aged 18 years or greater
• Must have a diagnosis of Intestinal Methane Overgrowth based on North American Consensus/American College of Gastroenterology established cutoffs
• Participants must report current symptoms of bloating, distention, abdominal pain, abdominal discomfort and constipation
• Participant must be an established patient at Northwestern Memorial Hospital

You may not qualify if:

• Participants who are already taking Atrantil
• Participants who are pregnant or breast-feeding
• Participants who cannot tolerate or are unwilling to complete a hydrogen-methane breath test at week 4.
• Inability to attend all study visits and complete survey data.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine Digestive Health Center

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome; Blind Loop Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Malabsorption Syndromes; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Darren Brenner, MD

  Northwestern Memorial Hospital/Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Surgery

Model Details: All participants receive 4 weeks (28 days)supply of Atrantil- 2 capsules 3 times per day .

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 16, 2021
• Study Start: September 18, 2020
• Primary Completion: September 26, 2022
• Study Completion: September 27, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)