Low FODMAP Diet and Gluten Free Diet in IBS

NCT06923696 | Completed

• 1 other identifier: nuhnacıyazgan
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The data of the research will be collected from patients who have applied to the Gastroenterology Polyclinic of Kayseri City Hospital or have previously been diagnosed with Irritable Bowel Syndrome (IBS). The data will be collected through face-to-face interviews using a questionnaire form. Participation in the study is entirely voluntary, and participants have the right to withdraw from the research at any time if they wish. The general flowchart of the research is shown in Figure 1. Figure 1. Flowchart of the Research Patients with IBS applying to the Gastroenterology Polyclinic: According to Rome IV criteria, individuals aged between 19-64, with BMI \>18.5 and \<29.9 kg/m2, non-cancerous, not using probiotics in the last month, and not following a gluten-free diet. Interview Group 1: Low FODMAP diet Group 2: Gluten-free diet Socio-demographic characteristics, general dietary habits, level of physical activity, anthropometric measurements, body composition analysis, IBS-SSS, IBS-QOL, IBS-VAS, Bristol Stool Scale, 24-hour retrospective food consumption record, Food Frequency Questionnaire. Second Interview (after 4 weeks) Anthropometric measurements, body composition analysis, IBS-SSS, IBS-QOL, IBS-VAS, Bristol Stool Scale, 3-day retrospective food consumption record.

Conditions

IBS - Irritable Bowel Syndrome; Diet, Healthy; Elimination Disorder With Fecal Symptoms

Keywords

IBS; diet therapy; gluten-free diet; fodmap diet; life quality

Outcome Measures

Primary Outcomes (4)

• Food consumption records

  The gluten-free diet is created by eliminating gluten-containing foods (such as wheat, barley, rye, etc.) from the diet. Permitted and forbidden foods are listed according to food groups, with general recommendations added at the end of the diet list. Participants will be provided with separate lists of permitted and forbidden foods for the low FODMAP diet and the gluten-free diet, along with general recommendations, and the diets will be explained to them. There will be no additional energy calculation or modified diet used in our study.

  To observe the effect of gluten free diet therapy on IBS quality of life after 1 month

• Food consumption records

  The low FODMAP diet involves the elimination of foods rich in fermentable oligo-, di-, monosaccharides and polyols, fructans, galactooligosaccharides (such as rye, barley, wheat, onions, and legumes), lactose-containing products (milk, yogurt, cheese), excessive fructose (apples, pears, watermelon, asparagus, honey), and foods rich in sorbitol, mannitol, and xylitol. It consists of a list indicating permitted and forbidden foods according to food groups. General recommendations are provided at the end of the diet list.

  "To observe the effect of low FODMAP diet therapy on IBS quality of life after 1 month."

• Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

  Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) will be used at the beginning and end of the study to assess the severity of symptoms of irritable bowel syndrome. To calculate symptom scores, participants will be asked 4 questions on a scale of 0 to 100. Based on the calculated score, the severity of the disease will be classified as follows: (0-74) for remission, (75-174) for mild, (175-299) for moderate, and (\>300) for severe.

  To observe the effect of diet therapy on GIS sypmtoms of life after 1 month."

• Quality of Life Scale in Irritable Bowel Syndrome Patients (IBS-QOL)

  The Irritable Bowel Syndrome Quality of Life Scale (IBS-QOL) will be applied at the beginning and end of the study to evaluate the level of quality of life of patients with irritable bowel syndrome. This questionnaire, designed for patients with irritable bowel syndrome, evaluates disease symptoms as well as the psychological, sociological effects of the disease, and its impact on individuals' sexual lives, among other topics. The questionnaire consists of 8 sub-scales, with 34 questions, allowing for the evaluation of quality of life on a scale of 100 points.

  To observe the effect of diet therapy on Quality of Life Scale of life after 1 month."

Study Arms (2)

Gluten free diet group

EXPERIMENTAL

Gluten-free diet therapy was implemented for 1 month

Behavioral: Diet therapy

LOW FODMAP diet group

EXPERIMENTAL

Low FODMAP diet therapy was implemented for 1 month

Behavioral: Diet therapy

Interventions

Diet therapy BEHAVIORAL

One of the groups will follow a gluten-free diet therapy, while the other will follow a LOW FODMAP diet.

Gluten free diet group; LOW FODMAP diet group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: 18-65 years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants between the ages of 18-65 who have been diagnosed with Irritable Bowel Syndrome (IBS) according to the Rome IV criteria,
• who are capable of making food choices independently,
• who do not have perception disorders or communication problems

You may not qualify if:

• Patients with inflammatory bowel disease
• celiac disease
• known lactose intolerance
• advanced cardiac, respiratory, renal, or hepatic diseases
• malignancy
• major psychiatric disorders, or a history of drug/alcohol abuse
• Patients with a history of previous abdominal surgery other than uncomplicated appendicitis
• pregnant and lactating patients

Sponsors & Collaborators

• Nuh Naci Yazgan University: lead

Study Sites (1)

Nuh Naci Yazgan University

Kocasinan, Kayseri̇, 38020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: asst.prof.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 11, 2025
• Study Start: July 27, 2023
• Primary Completion: August 25, 2024
• Study Completion: September 9, 2024
• Last Updated: April 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)