Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome

NCT05646186 | Unknown

• 1 other identifier: E-10840098-772.02-5763
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

irritable bowel syndrome (IBS) is a well-known risk factor for diseases of the anal region (hemorrhoids, anal fissures, etc.) and large intestine (colon cancer, diverticular disease). Untreatable IBS disease not only impairs the patient's quality of life but also reduces the success of surgical treatment in these diseases. Today, only one-third of IBS patients achieve successful results with the treatment methods and diets used routinely. Balancing the composition of the gut microbiota may yield satisfactory results in this patient group. With the results of our study, we aim to reveal the effect of microbiome analysis and personalized diet on symptoms and its place in treatment in patients with IBS disease. Patients applying to Gastroenterology outpatient clinics in respective centers due to IBS will be randomized into two groups. The patients in the control group will follow the FODMAP diet protocol for IBS; In the study group, a personalized diet will be applied according to the gut microbiota. No nutritional supplements will be used in either group. Changes in defecation habits and quality of life scale of both groups will be evaluated at the end of 6 weeks and the results will be compared.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Irritable Bowel Syndrome With Constipation; Irritable Bowel Syndrome Mixed

Keywords

Microbiome; Microbiota; Personalised medicine; Artificial intelligence

Outcome Measures

Primary Outcomes (3)

• Change in IBS Symptom severity score

  Change in IBS Symptom severity score after 6 weeks of dietary intervention

  6 weeks

• Change in IBS quality of life scale

  Change in IBS quality of life scale after 6 weeks of dietary intervention

  6 weeks

• Change in Anxiety-depression scale

  Change in Anxiety and depression scale after 6 weeks of dietary intervention

  6 weeks

Secondary Outcomes (1)

• Difference between study and control arms

  6 months

Study Arms (2)

Personalised diet based on microbiome analysis

EXPERIMENTAL

Personalized diet application based on artificial intelligence-assisted microbiome analysis. After the microbiome analysis is made from the stool samples to be taken from the individuals, a personalized diet program will be created with an artificial intelligence-based algorithm and a diet will be applied for 6 weeks with the support of a professional dietitian.

Dietary Supplement: Personalized dietary intervention based on microbiome analysis

Low FODMAP diet

ACTIVE COMPARATOR

After the microbiome analysis is made from the stool samples to be taken from the individuals, low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet will be applied for 6 weeks with the support of a professional dietitian.

Dietary Supplement: Low-FODMAP diet

Interventions

Personalized dietary intervention based on microbiome analysis DIETARY_SUPPLEMENT

Personalized dietary intervention based on individual microbiome analysis

Also known as: Enbiosis IBS Scheme

Personalised diet based on microbiome analysis

Low-FODMAP diet DIETARY_SUPPLEMENT

Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet

Low FODMAP diet

Eligibility Criteria

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

You may qualify if:

• To be between the ages of 18-65
• To be diagnosed with IBS (IBS-D, IBS-C, IBS-M) according to the Rome IV Criteria
• To give consent to participate in the study voluntarily
• Being a smartphone and/or internet user (for dietitian follow-up and clinical follow-up)

You may not qualify if:

• Pregnant or planning to become pregnant
• Having another known diagnosis of gastrointestinal disease (inflammatory bowel disease, malabsorption of any macronutrient, intestinal resection, celiac disease, etc.)
• Colonoscopy history (in the last 1 year)
• History of abdominal surgery other than appendectomy or hysterectomy
• Psychiatric comorbidity
• Chronic diseases that will affect the microbiome (cancer, diabetes, cardiovascular disease, liver diseases, neurological diseases, etc.)
• Use of drugs that may affect digestive function in the 4 weeks prior to the study (antibiotics (including use in the last 4 weeks), probiotics, narcotic analgesics, lactulose (prebiotics))
• Patients taking dietary supplements
• Excluded from the study if following a restricted diet.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• Bozyaka Training and Research Hospital: collaborator
• Tepecik Training and Research Hospital: collaborator
• Dr. Ersin Arslan Education and Training Hospital: collaborator

Study Sites (1)

Medipol University Bahcelievler Hospital

Istanbul, 34196, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Tunali V, Arslan NC, Ermis BH, Dervis Hakim G, Gundogdu A, Hora M, Nalbantoglu OU. A Multicenter Randomized Controlled Trial of Microbiome-Based Artificial Intelligence-Assisted Personalized Diet vs Low-Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet: A Novel Approach for the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2024 Sep 1;119(9):1901-1912. doi: 10.14309/ajg.0000000000002862. Epub 2024 May 8.

  PMID: 38717025 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Central Study Contacts

Varol TUNALI, Dr.

CONTACT

00905556303231; varoltunali@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: This is a double-blinded randomized controlled study. The participants will be blinded to the dietary interventions and the care providers will apply the diets that were allocated to them without knowing which diet they are applying. The investigators will not be able to obtain data until the data collection is finished.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: December 12, 2022
• Study Start: October 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: December 31, 2023
• Last Updated: December 12, 2022

Record last verified: 2022-09

Locations

TU (1)