Comparison of the Effects of Different Nutrition Treatments on Patients With Irritable Bowel Syndrome

NCT04853381 | Completed

• 1 other identifier: nolule
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable Bowel Syndrome (IBS) is a disease associated with changes in bowel habits characterized by unexplained abdominal discomfort or pain. Common symptoms of the disease include gas, bloating, diarrhea, constipation, and common gastrointestinal problems associated with psychosocial problems. IBS makes it difficult for patients to attend school and work, reduce productivity, increase healthcare costs and negatively affect quality of life. Although IBS is not a life-threatening disease, it is a condition that must be tackled throughout life. The disease is clinically managed through dietary interventions and appropriate lifestyle changes, and pharmacological symptom-targeted or psychological treatments. The aim of this study is to determine the effects of different dietary treatment methods on patients 'severity symptom score and quality of life, and the patients' compliance with different dietary treatments.

Conditions

Irritable Bowel Syndrome

Keywords

low FODMAP; gluten free diet; irritable bowel syndrome

Outcome Measures

Primary Outcomes (6)

• Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)

  this test evaluates the severity of the disease. The overall score of IBS-SSS ranges from 0 to 500. According to this standardized survey, 75-175 points: mild symptom 175--300 points: moderate symptom \> 300 points: considered to be severe symptoms.

  at baseline

• Irritable Bowel Syndrome Severity Scoring Scale (IBS-SSS)

  this test evaluates the severity of the disease. The overall score of IBS-SSS ranges from 0 to 500. According to this standardized survey, 75-175 points: mild symptom 175--300 points: moderate symptom \> 300 points: considered to be severe symptoms.

  end of the 4th week.

• Irritable Bowel Syndrome Quality of Life Scale (IBS-QQL)

  This test determines the quality of life of patients with irritable bowel syndrome. Irritable Bowel Syndrome Quality of Life Scale consists of 34 items and 8 subgroups; Each item in a Likert-type scale has 5 answer options. "1 Nothing", "2 A Little"; "3 Middle"; One of the "4 Too Much" and "5 Too Much" options should be selected. According to these options, the first option is 5; The fifth option is given 1 point and the total score is calculated. Minimum 34 points and maximum 170 points are obtained as total points. An increase in the total score obtained from the scale indicates an increase in the quality of life associated with the disease.

  at baseline

• Irritable Bowel Syndrome Quality of Life Scale (IBS-QQL)

  This test determines the quality of life of patients with irritable bowel syndrome. Irritable Bowel Syndrome Quality of Life Scale consists of 34 items and 8 subgroups; Each item in a Likert-type scale has 5 answer options. "1 Nothing", "2 A Little"; "3 Middle"; One of the "4 Too Much" and "5 Too Much" options should be selected. According to these options, the first option is 5; The fifth option is given 1 point and the total score is calculated. Minimum 34 points and maximum 170 points are obtained as total points. An increase in the total score obtained from the scale indicates an increase in the quality of life associated with the disease.

  end of the 4th week

• Bristol Stool Scale

  This test questions the shape and consistency of stool in patients with irritable bowel syndrome. This scale aims to estimate the stool form from 7 different stool shapes. It is understood that there is improvement in the stool form as you approach the number 4 form.

  at baseline

• Bristol Stool Scale

  This test questions the shape and consistency of stool in patients with irritable bowel syndrome. This scale aims to estimate the stool form from 7 different stool shapes. It is understood that there is improvement in the stool form as you approach the number 4 form.

  end of the 4th week

Secondary Outcomes (4)

• Food Consumption Frequency Survey including FODMAP Intake

  at baseline

• Food Consumption Frequency Survey including FODMAP Intake

  end of the 4th week

• Food Consumption Frequency Survey Including Gluten Intake

  at baseline

• Food Consumption Frequency Survey Including Gluten Intake

  end of the 4th week

Study Arms (4)

1st Group: Traditional diet recommendations

EXPERIMENTAL

Traditional diet recommendations will apply for 4 weeks.

Other: dietary treatment (Traditional diet recommendations)

2nd Group: Low FODMAP diet

EXPERIMENTAL

Low FODMAP diet recommendations will apply for 4 weeks. When individuals are first enrolled in the study, they will be trained by the dietician for one hour before the medical nutrition treatment they will apply for 4 weeks.

Other: dietary treatment (low FODMAP)

3rd Group: Gluten-free diet

EXPERIMENTAL

Gluten-free diet recommendations will apply for 4 weeks. When individuals are first enrolled in the study, they will be trained by the dietician for one hour before the medical nutrition treatment they will apply for 4 weeks.

Other: dietary treatment (gluten free)

4th Group: Low-FODMAP gluten-free diet

EXPERIMENTAL

Low-FODMAP gluten-free diet recommendations will apply for 4 weeks. When individuals are first enrolled in the study, they will be trained by the dietician for one hour before the medical nutrition treatment they will apply for 4 weeks.

Other: dietary treatment (low FODMAP+gluten free)

Interventions

dietary treatment (low FODMAP) OTHER

The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.

2nd Group: Low FODMAP diet

dietary treatment (gluten free) OTHER

The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.

3rd Group: Gluten-free diet

dietary treatment (low FODMAP+gluten free) OTHER

The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.

4th Group: Low-FODMAP gluten-free diet

dietary treatment (Traditional diet recommendations) OTHER

The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.

1st Group: Traditional diet recommendations

Eligibility Criteria

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

You may qualify if:

• Applying to Gaziantep University Faculty of Medicine Department of Gastroenterology,
• Between the ages of 19-65,
• Diagnosed with Irritable Bowel Syndrome by a physician according to Rome IV criteria,
• Patients who voluntarily accept to participate in the study will be included in the study after explaining the purpose and method of the study.

You may not qualify if:

• Those with gastrointestinal organic diseases (celiac, lactose intolerance, inflammatory bowel diseases),
• Those diagnosed with clinically important systemic diseases (diabetes, cancer, hypertension, thyroid and other endocrine system diseases),
• Individuals diagnosed with multiple sclerosis and Parkinson's disease,
• Individuals with established food allergies,
• Individuals with major psychiatric diseases,
• Individuals with eating disorders according to DSM-V criteria,
• Individuals who have undergone major abdominal surgery,
• Individuals who were pregnant at the time of the study will not be included in the study.

Sponsors & Collaborators

• University of Gaziantep: lead

Study Sites (1)

Gaziantep University

Gaziantep, Sehitkamil, 27060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• S.Mine YURTTAGUL

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 21, 2021
• Study Start: April 21, 2021
• Primary Completion: December 22, 2021
• Study Completion: January 12, 2022
• Last Updated: May 18, 2022

Record last verified: 2022-05

Locations

TU (1)