Irritable Bowel SyndromeNCT04755673
Atrantil for Intestinal Bacterial Overgrowth
A study testing Atrantil (Medical Food) in people with Irritable Bowel Syndrome and Bacterial Overgrowth Syndrome, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome, Bacterial Overgrowth Syndrome, SIBO
- What is being tested?
- Atrantil (Medical Food)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 27 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Medicine Digestive Health Center
Chicago, Illinois, 60611
About this study
Official title: Open-Label Assessment of the Efficacy of Atrantil In the Treatment of Methane-Predominate Intestinal Bacterial Overgrowth
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.
Read the 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.
- Being tested
- Atrantil (Medical Food)
- Medical subject headings
- Irritable Bowel Syndrome, Blind Loop Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Atrantil (Medical Food) | Experimental | All participants in the trial will take two capsules of Atrantil three times a day for 28 days. Receives: Other: Atrantil (Medical Food) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Change from Baseline at four weeks.
Secondary outcomes (3)
Change in quality of life as measured by Short Form- 12.
SF-12 scale is a generic, multipurpose short-form survey with 12 questions selected from the SF-36 Health Survey to evaluate overall health-related quality of life. Answers are combined, scored and weighted into mental and physical functioning component scales. The scores for each scale range from 0 to 100. A higher value indicates a better quality of life of the patient.
Measured: Change from Baseline at four weeks.
Change in Quality of life as measured by the PROMIS-Global Health (PROMIS-GH)
PROMIS® Global Health Short Form (10 items). The 10 global health items include ratings of the five core PROMIS domains. It includes the most widely used self-rated health item (global01). PROMIS® includes a single item that provides a pure rating of physical health (global03) and another item for mental health (global04). Also included is an overall quality of life item (global02). The remaining items provide global ratings of physical function (global06), fatigue (global08), pain (global07), emotional distress (global10), and social health (global05 and global09). The 10 PROMIS® Global Health items each have 5 response choices, with the exception of the common 11-point pain intensity item ("How would you rate your pain on average" with 0=No pain and 10=Worst imaginable pain). Global 1-5, 9 range from 5 (Excellent) to 1 (Poor), with higher numbers meaning greater health. Certain items are restored (Global 7 such that 5=0 no pain, and 1=10 worst pain), Global8 (5=None, 1=Very Severe),
Measured: Change from Baseline at four weeks.
Change in methane as measured by hydrogen methane breath-test pre and post-treatment.
Methane levels equal to or more than 10 parts per million are considered abnormal and positive for intestinal methane overgrowth. Methane levels under 10 are considered normal and negative for intestinal methane overgrowth.
Measured: Post-Treatment (+-3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start18 Sep 2020
- Primary completion26 Sep 2022
- Study completion27 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive 4 weeks (28 days)supply of Atrantil- 2 capsules 3 times per day .
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darren Brenner, Northwestern University
- Investigators
- Darren Brenner, MD, Principal investigator, Northwestern Memorial Hospital/Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755673
- Sponsor's protocol ID
- STU00212557
- Status last verified
- Jan 2023
- First submitted
- 2 Feb 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Assessment of the Efficacy of Atrantil In the Treatment of Methane-Predominate Intestinal Bacterial Overgrowth
- ClinicalTrials.gov ID
- NCT04755673
- Acronym / sponsor ID
- STU00212557
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 26 Sep 2022 (actual)
- Study completion
- 27 Sep 2022 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive 4 weeks (28 days)supply of Atrantil- 2 capsules 3 times per day .
| Arm | Type | Receives |
|---|---|---|
| Experimental: Atrantil (Medical Food) | Experimental | Other: Atrantil (Medical Food)All participants in the trial will take two capsules of Atrantil three times a day for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental: Atrantil (Medical Food) |
Primary outcome
Change in clinical symptoms of Intestinal Methane Overgrowth as measured by daily Numeric Rating Scale (NRS) measuring pain, bloating, distention, and discomfort.
Time frame: Daily for 28 days
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.
Change in clinical symptoms of Intestinal Methane Overgrowth as measured by Patient Reported Outcome Measures Information Systems Gastrointestinal Symptoms Scale (PROMIS-GI)
Time frame: Change from Baseline at four weeks.
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 in clinical symptoms of Intestinal Methane Overgrowth as measured by the Bristol Stool Scale (BSS)
Time frame: Change from Baseline at four weeks.
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
3 secondary outcomes
Change in quality of life as measured by Short Form- 12.
Time frame: Change from Baseline at four weeks.
Change in Quality of life as measured by the PROMIS-Global Health (PROMIS-GH)
Time frame: Change from Baseline at four weeks.
Change in methane as measured by hydrogen methane breath-test pre and post-treatment.
Time frame: Post-Treatment (+-3 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Brenner, MD principal investigator
Northwestern Memorial Hospital/Feinberg School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atrantil (Medical Food) in people with Irritable Bowel Syndrome and Bacterial Overgrowth Syndrome, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical symptoms of Intestinal Methane Overgrowth as measured by daily Numeric Rating Scale (NRS) measuring pain, bloating, distention, and discomfort. (time frame: Daily for 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.