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

Primary Purpose

Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Personalized dietary intervention based on microbiome analysis
Low-FODMAP diet
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Microbiome, Microbiota, Personalised medicine, Artificial intelligence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Not meeting any of the exclusion criteria Exclusion Criteria: 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.

Sites / Locations

  • Medipol University Bahcelievler HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Personalised diet based on microbiome analysis

Low FODMAP diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in IBS Symptom severity score
Change in IBS Symptom severity score after 6 weeks of dietary intervention
Change in IBS quality of life scale
Change in IBS quality of life scale after 6 weeks of dietary intervention
Change in Anxiety-depression scale
Change in Anxiety and depression scale after 6 weeks of dietary intervention

Secondary Outcome Measures

Difference between study and control arms
A statistically significant difference between study and control groups based on the IBS-SSS, IBS-QOL and Anxiety depression scale

Full Information

First Posted
October 6, 2022
Last Updated
December 2, 2022
Sponsor
Istanbul Medipol University Hospital
Collaborators
Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital, Dr. Ersin Arslan Education and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05646186
Brief Title
Personalized Dietary Intervention Based on Microbiome Analysis vs FODMAP Diet for Irritable Bowel Syndrome
Official Title
Comparison of Personalized Diet Implementation Based on Microbiome Analysis and FODMAP Diet Efficacy in Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital
Collaborators
Bozyaka Training and Research Hospital, Tepecik Training and Research Hospital, Dr. Ersin Arslan Education and Training Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome Mixed
Keywords
Microbiome, Microbiota, Personalised medicine, Artificial intelligence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Personalised diet based on microbiome analysis
Arm Type
Experimental
Arm Description
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.
Arm Title
Low FODMAP diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Personalized dietary intervention based on microbiome analysis
Other Intervention Name(s)
Enbiosis IBS Scheme
Intervention Description
Personalized dietary intervention based on individual microbiome analysis
Intervention Type
Dietary Supplement
Intervention Name(s)
Low-FODMAP diet
Intervention Description
Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols diet
Primary Outcome Measure Information:
Title
Change in IBS Symptom severity score
Description
Change in IBS Symptom severity score after 6 weeks of dietary intervention
Time Frame
6 weeks
Title
Change in IBS quality of life scale
Description
Change in IBS quality of life scale after 6 weeks of dietary intervention
Time Frame
6 weeks
Title
Change in Anxiety-depression scale
Description
Change in Anxiety and depression scale after 6 weeks of dietary intervention
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Difference between study and control arms
Description
A statistically significant difference between study and control groups based on the IBS-SSS, IBS-QOL and Anxiety depression scale
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Not meeting any of the exclusion criteria Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Varol TUNALI, Dr.
Phone
00905556303231
Email
varoltunali@gmail.com
Facility Information:
Facility Name
Medipol University Bahcelievler Hospital
City
Istanbul
ZIP/Postal Code
34196
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osman Civil, MD
Phone
+905058334286
Email
dr.ocivil@hotmail.com
First Name & Middle Initial & Last Name & Degree
Naciye Cigdem Arslan, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Individual participant data will be made available in a data repository

Learn more about this trial

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

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