Irritable Bowel SyndromeNCT03269032

Mediterranean Diet and the Gut Microbiome

A study testing American Diet and Mediterranean-style Diet in people with Irritable Bowel Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the impact of a Mediterranean-style diet on microbiome diversity compared to a typical American diet. The study will observe the microbiome composition comparisons in healthy volunteers as well as in patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) to see if the consumption of a… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: American Diet and Mediterranean-style Diet
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 10 Oct 2017to 1 Jan 2021
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

must be willing to eat pre-prepared foods for 4 weeks
subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet.
Phase 2 subjects- must have diagnosis of IBS based on Rome III criteria and have diarrhea-predominant disease, defined as >50% of bowel movements characterized as diarrhea

Who cannot join

history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance
diabetes mellitus
congestive heart failure
coronary artery disease
chronic liver disease or end stage renal disease
pregnancy or breastfeeding
trainees under the direct supervision of the PI and patients receiving direct ongoing medical care from the PI or Co-I will not be enrolled as subjects in this study

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Heath
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Impact of the Mediterranean Diet on the Gut Microbiome and Symptoms of Diarrhea-Predominant Irritable Bowel Syndrome

Read the detailed description

Irritable bowel syndrome (IBS) is the most prevalent and well-studied functional gastrointestinal disorder. While IBS has no direct mortality, it does compromise quality of life, incurs morbidity, and has a substantial economic impact on society. The gut microbiome may play a significant role in the pathogenesis of IBS. Even though the exact mechanisms underlying this relationship have not been presented, it is suggested that certain microorganisms may increase gut permeability, activate the mucosal immune response, increase visceral sensitivity and alter intestinal motility via a bidirectional brain-gut interaction. Recent studies suggest that the salutary impact of the Mediterranean diet may be due to its effects on the composition of the gut microbiome. In a recent cohort study in Italy, subjects who adhered most closely to a classical Mediterranean diet had more favorable bacterial enterotypes (e.g., Prevotella) in their stool, as well as higher levels of short-chain fatty acids - which are essential for colonic function. Studies have also showed that diet alters the predominant microbiome enterotypes and that microbiome composition can change quickly, within 24 hours, after a dietary intervention. Therefore, consumption of a Mediterranean diet may ameliorate the gut dysbiosis associated with IBS-D.

Conditions: Irritable Bowel Syndrome
Being tested: American Diet, Mediterranean-style Diet
Keywords: Mediterranean diet, gut microbiome, gastrointestinal
Medical subject headings: Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

American DietOther
According to National Health and Nutritional Examination Survey (NHANES) data, the nutritional composition of the baseline typical American diet is 50%Carbohydrates, 15% Protein, 35% Fat, >11% Saturated Fatty Acids, <12% Monounsaturated Fatty Acids, and >8% Polyunsaturated Fatty Acids.
Participants will receive 3 meals and 1 snack for each day during the study period.
Mediterranean-style DietOther
The nutritional composition of the baseline typical Mediterranean-style diet is 46% Carbohydrates/Alcohol (red wine will be included in the Mediterranean diet only), 17% Protein, 32% Fat, <7% Saturated Fatty Acids, >18% Monounsaturated Fatty Acids and <5% Polyunsaturated Fatty Acids.
Participants will receive 3 meals and 1 snack for each day during the study period.

Study groups in NCT03269032
Study group	Role	What they receive
Phase 1 Healthy Volunteers	Experimental	Healthy volunteers will eat a typical American diet for 2 weeks and then eat a Mediterranean-style diet for 2 weeks. Receives: Other: American Diet; Other: Mediterranean-style Diet
Phase 2 IBS Patients	Experimental	Participants with IBS will eat a typical American diet for 2 weeks and then eat a Mediterranean-style diet for 2 weeks Receives: Other: American Diet; Other: Mediterranean-style Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase 1- Change in predominant enterotypes and diversity of fecal microbiota
Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples collected from the healthy volunteer participants in phase 1.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.
Measured: Baseline, 2 weeks, 4 weeks
Phase 2-Change in predominant enterotypes and diversity of fecal microbiota
Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples and rectal biopsies performed on the subjects with IBS-D in phase 2.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.
Measured: Baseline, 2 weeks, 4 weeks

Secondary outcomes (4)

Changes in plasma inflammatory marker - Erythrocyte sedimentation rate (ESR)
A plasma inflammatory marker that will be analyzed is the Erythrocyte sedimentation rate (ESR). Data will be analyzed in comparison of time points Baseline, 2 weeks and 4 weeks.
Measured: Baseline, 2 weeks, 4 weeks
Changes in plasma inflammatory marker - C-reactive protein (CPR)
A plasma inflammatory marker that will be analyzed is C-reactive protein (CRP). The CRP is measured through a blood test. A CRP level of 10mg/L or lower is considered to be normal. A higher CRP indicates that their is inflammation in the body.Data will be analyzed in comparison of time points Baseline, 2 weeks and 4 weeks.
Measured: Baseline, 2 weeks, 4 weeks
Changes in IBS Symptom Severity Scores
The IBS Severity Scoring System is a validated measure to assess the severity of IBS symptoms, and can help monitor response to treatment. Each of the 5 questions generates a score from 0-100 points with a maximum total score of 500 points. Mild IBS=75-174 points, moderate IBS=175-299 points, and severe IBS=300 points of more.Data will be analyzed in comparison of time points Baseline, 2 weeks and 4 weeks.
Measured: Baseline, 2 weeks, 4 weeks
Changes in Hospital Anxiety and Depression Scores
Hospital Anxiety and Depression Scores (HADS) is a self assessment scale designed to detect states of depression, anxiety, and emotional distress in patients who are being treated for a clinical problem. The scale has 14 questions that are scored on a scale of 0-3, with 3 indicating higher symptom frequencies. Scores for each subscale (anxiety and depression) range from 0 to 21 with scores categorized as follows: normal 0-7, mild 8-10, moderate 11-14, and severe 15-21. Scores for the entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.Data will be analyzed in comparison of time points Baseline, 2 weeks and 4 weeks.
Measured: Baseline, 2 weeks, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 20171 Jan 2021

First posted31 Aug 2017
Study start10 Oct 2017
Primary completion1 Jan 2021
Study completion1 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
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: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Model description: The study will have two phases, Phase 1 will study healthy subjects, who will follow a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet for 2 weeks. Phase 2 will study subjects who have IBS-D. As above, they will first eat a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet.
Masking: Single blind
Who is masked: Participant
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03269032
Sponsor's protocol ID: IRB00039422
Status last verified: Oct 2021
First submitted: 30 Aug 2017
Last updated: 22 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Cresci GA, Bawden E. Gut Microbiome: What We Do and Don't Know. Nutr Clin Pract. 2015 Dec;30(6):734-46. doi: 10.1177/0884533615609899. Epub 2015 Oct 8.
PubMed 26449893
Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.
PubMed 25199904
Shanahan F, Quigley EM. Manipulation of the microbiota for treatment of IBS and IBD-challenges and controversies. Gastroenterology. 2014 May;146(6):1554-63. doi: 10.1053/j.gastro.2014.01.050. Epub 2014 Jan 28.
PubMed 24486051
Del Chierico F, Vernocchi P, Dallapiccola B, Putignani L. Mediterranean diet and health: food effects on gut microbiota and disease control. Int J Mol Sci. 2014 Jul 1;15(7):11678-99. doi: 10.3390/ijms150711678.
PubMed 24987952
De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.
PubMed 26416813
Mayer EA, Savidge T, Shulman RJ. Brain-gut microbiome interactions and functional bowel disorders. Gastroenterology. 2014 May;146(6):1500-12. doi: 10.1053/j.gastro.2014.02.037. Epub 2014 Feb 28.
PubMed 24583088
De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.
PubMed 20679230
Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
PubMed 21885731
Wang Q, Garrity GM, Tiedje JM, Cole JR. Naive Bayesian classifier for rapid assignment of rRNA sequences into the new bacterial taxonomy. Appl Environ Microbiol. 2007 Aug;73(16):5261-7. doi: 10.1128/AEM.00062-07. Epub 2007 Jun 22.
PubMed 17586664
Schloss PD, Westcott SL, Ryabin T, Hall JR, Hartmann M, Hollister EB, Lesniewski RA, Oakley BB, Parks DH, Robinson CJ, Sahl JW, Stres B, Thallinger GG, Van Horn DJ, Weber CF. Introducing mothur: open-source, platform-independent, community-supported software for describing and comparing microbial communities. Appl Environ Microbiol. 2009 Dec;75(23):7537-41. doi: 10.1128/AEM.01541-09. Epub 2009 Oct 2.
PubMed 19801464
Weinberg RB, Dantzker C, Patton CS. Sensitivity of serum apolipoprotein A-IV levels to changes in dietary fat content. Gastroenterology. 1990 Jan;98(1):17-24. doi: 10.1016/0016-5085(90)91285-e.
PubMed 2104541
McCombs RJ, Marcadis DE, Ellis J, Weinberg RB. Attenuated hypercholesterolemic response to a high-cholesterol diet in subjects heterozygous for the apolipoprotein A-IV-2 allele. N Engl J Med. 1994 Sep 15;331(11):706-10. doi: 10.1056/NEJM199409153311104.
PubMed 8058077
Mishra SP, Wang B, Jain S, Ding J, Rejeski J, Furdui CM, Kitzman DW, Taraphder S, Brechot C, Kumar A, Yadav H. A mechanism by which gut microbiota elevates permeability and inflammation in obese/diabetic mice and human gut. Gut. 2023 Oct;72(10):1848-1865. doi: 10.1136/gutjnl-2022-327365. Epub 2023 Mar 22.
PubMed 36948576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of the Mediterranean Diet on the Gut Microbiome and Symptoms of Diarrhea-Predominant Irritable Bowel Syndrome
ClinicalTrials.gov ID: NCT03269032
Acronym / sponsor ID: IRB00039422
Conditions: Irritable Bowel Syndrome
Keywords: Mediterranean diet, gut microbiome, gastrointestinal
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 10 Oct 2017 (actual)
Primary completion: 1 Jan 2021 (actual)
Study completion: 1 Jan 2021 (actual)
First posted: 31 Aug 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: The study will have two phases, Phase 1 will study healthy subjects, who will follow a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet for 2 weeks. Phase 2 will study subjects who have IBS-D. As above, they will first eat a typical American diet for 2 weeks, and then cross-over to a Mediterranean-style diet.

Arm	Type	Receives
Phase 1 Healthy Volunteers	Experimental	Other: American Diet, Other: Mediterranean-style DietHealthy volunteers will eat a typical American diet for 2 weeks and then eat a Mediterranean-style diet for 2 weeks.
Phase 2 IBS Patients	Experimental	Other: American Diet, Other: Mediterranean-style DietParticipants with IBS will eat a typical American diet for 2 weeks and then eat a Mediterranean-style diet for 2 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

must be willing to eat pre-prepared foods for 4 weeks
subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a Mediterranean diet.
Phase 2 subjects- must have diagnosis of IBS based on Rome III criteria and have diarrhea-predominant disease, defined as >50% of bowel movements characterized as diarrhea

Key exclusion criteria (7 listed)

history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance
diabetes mellitus
congestive heart failure
coronary artery disease
chronic liver disease or end stage renal disease

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
American DietAccording to National Health and Nutritional Examination Survey (NHANES) data, the nutritional composition of the baseline typical American diet is 50%Carbohydrates, 15% Protein, 35% Fat, >11% Saturated Fatty Acids, <12% Monounsaturated Fatty Acids, and >8% Polyunsaturated Fatty Acids. Participants will receive 3 meals and 1 snack for each day during the study period.	Other	Phase 1 Healthy Volunteers, Phase 2 IBS Patients
Mediterranean-style DietThe nutritional composition of the baseline typical Mediterranean-style diet is 46% Carbohydrates/Alcohol (red wine will be included in the Mediterranean diet only), 17% Protein, 32% Fat, <7% Saturated Fatty Acids, >18% Monounsaturated Fatty Acids and <5% Polyunsaturated Fatty Acids. Participants will receive 3 meals and 1 snack for each day during the study period.	Other	Phase 1 Healthy Volunteers, Phase 2 IBS Patients

Primary outcome

Phase 1- Change in predominant enterotypes and diversity of fecal microbiota
Time frame: Baseline, 2 weeks, 4 weeks
Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples collected from the healthy volunteer participants in phase 1.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.
Phase 2-Change in predominant enterotypes and diversity of fecal microbiota
Time frame: Baseline, 2 weeks, 4 weeks
Fecal microbiota diversity and enterotypes will be determined through bacterial 16S rRNA gene sequences on stool samples and rectal biopsies performed on the subjects with IBS-D in phase 2.The data will initially be analyzed by calculating descriptive statistics and plotting to examine for potential outliers and the necessity for data transformation.

4 secondary outcomes

Changes in plasma inflammatory marker - Erythrocyte sedimentation rate (ESR)
Time frame: Baseline, 2 weeks, 4 weeks
Changes in plasma inflammatory marker - C-reactive protein (CPR)
Time frame: Baseline, 2 weeks, 4 weeks
Changes in IBS Symptom Severity Scores
Time frame: Baseline, 2 weeks, 4 weeks
Changes in Hospital Anxiety and Depression Scores
Time frame: Baseline, 2 weeks, 4 weeks

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 22 Mar 2023.
Background: PubMed 26449893Cresci GA, Bawden E. Gut Microbiome: What We Do and Don't Know. Nutr Clin Pract. 2015 Dec;30(6):734-46. doi: 10.1177/0884533615609899. Epub 2015 Oct 8.
Background: PubMed 25199904Canavan C, West J, Card T. Review article: the economic impact of the irritable bowel syndrome. Aliment Pharmacol Ther. 2014 Nov;40(9):1023-34. doi: 10.1111/apt.12938. Epub 2014 Sep 9.
Background: PubMed 24486051Shanahan F, Quigley EM. Manipulation of the microbiota for treatment of IBS and IBD-challenges and controversies. Gastroenterology. 2014 May;146(6):1554-63. doi: 10.1053/j.gastro.2014.01.050. Epub 2014 Jan 28.
Background: PubMed 24987952Del Chierico F, Vernocchi P, Dallapiccola B, Putignani L. Mediterranean diet and health: food effects on gut microbiota and disease control. Int J Mol Sci. 2014 Jul 1;15(7):11678-99. doi: 10.3390/ijms150711678.
Background: PubMed 26416813De Filippis F, Pellegrini N, Vannini L, Jeffery IB, La Storia A, Laghi L, Serrazanetti DI, Di Cagno R, Ferrocino I, Lazzi C, Turroni S, Cocolin L, Brigidi P, Neviani E, Gobbetti M, O'Toole PW, Ercolini D. High-level adherence to a Mediterranean diet beneficially impacts the gut microbiota and associated metabolome. Gut. 2016 Nov;65(11):1812-1821. doi: 10.1136/gutjnl-2015-309957. Epub 2015 Sep 28.
Background: PubMed 24583088Mayer EA, Savidge T, Shulman RJ. Brain-gut microbiome interactions and functional bowel disorders. Gastroenterology. 2014 May;146(6):1500-12. doi: 10.1053/j.gastro.2014.02.037. Epub 2014 Feb 28.
Background: PubMed 20679230De Filippo C, Cavalieri D, Di Paola M, Ramazzotti M, Poullet JB, Massart S, Collini S, Pieraccini G, Lionetti P. Impact of diet in shaping gut microbiota revealed by a comparative study in children from Europe and rural Africa. Proc Natl Acad Sci U S A. 2010 Aug 17;107(33):14691-6. doi: 10.1073/pnas.1005963107. Epub 2010 Aug 2.
Background: PubMed 21885731Wu GD, Chen J, Hoffmann C, Bittinger K, Chen YY, Keilbaugh SA, Bewtra M, Knights D, Walters WA, Knight R, Sinha R, Gilroy E, Gupta K, Baldassano R, Nessel L, Li H, Bushman FD, Lewis JD. Linking long-term dietary patterns with gut microbial enterotypes. Science. 2011 Oct 7;334(6052):105-8. doi: 10.1126/science.1208344. Epub 2011 Sep 1.
Background: PubMed 17586664Wang Q, Garrity GM, Tiedje JM, Cole JR. Naive Bayesian classifier for rapid assignment of rRNA sequences into the new bacterial taxonomy. Appl Environ Microbiol. 2007 Aug;73(16):5261-7. doi: 10.1128/AEM.00062-07. Epub 2007 Jun 22.
Background: PubMed 19801464Schloss PD, Westcott SL, Ryabin T, Hall JR, Hartmann M, Hollister EB, Lesniewski RA, Oakley BB, Parks DH, Robinson CJ, Sahl JW, Stres B, Thallinger GG, Van Horn DJ, Weber CF. Introducing mothur: open-source, platform-independent, community-supported software for describing and comparing microbial communities. Appl Environ Microbiol. 2009 Dec;75(23):7537-41. doi: 10.1128/AEM.01541-09. Epub 2009 Oct 2.
Background: PubMed 2104541Weinberg RB, Dantzker C, Patton CS. Sensitivity of serum apolipoprotein A-IV levels to changes in dietary fat content. Gastroenterology. 1990 Jan;98(1):17-24. doi: 10.1016/0016-5085(90)91285-e.
Background: PubMed 8058077McCombs RJ, Marcadis DE, Ellis J, Weinberg RB. Attenuated hypercholesterolemic response to a high-cholesterol diet in subjects heterozygous for the apolipoprotein A-IV-2 allele. N Engl J Med. 1994 Sep 15;331(11):706-10. doi: 10.1056/NEJM199409153311104.
Individual participant dataSharing planned: Undecided

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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.

Richard B Weinberg, MD principal investigator

Wake Forest University Health Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing American Diet and Mediterranean-style Diet in people with Irritable Bowel Syndrome, run by Wake Forest University Health Sciences 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 3 inclusion and 7 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 22 Mar 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?

Phase 1- Change in predominant enterotypes and diversity of fecal microbiota (time frame: Baseline, 2 weeks, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03269032, which also lists 13 linked publications.

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 22 Mar 2023.