The Effect of Inulin in Irritable Bowel Syndrome

September 20, 2024 updated by: Çağlar Akçalı, Mardin Artuklu University

The Effect of Inulin on Intestinal Symptoms, Depression and Quality of Life in Individuals With Constipation-Predominant Irritable Bowel Syndrome

Purpose: This study was conducted to evaluate the effect of inulin on bowel symptoms, depression and quality of life in individuals with constipation-dominant irritable bowel syndrome. Individuals (n=34) aged 21-63 years with constipation-dominant IBS were included in the study. Individuals were divided into two groups as prebiotic group [(n=17) (inulin/oligofructose 50/50 mixture of 4.6 g (Inulin=total 9.2 g) inulin/oligofructose 50/50 mixture twice a day)], and placebo [(n=17), (Maltodextrin=9.2 g)] group. The intervention period was 8 weeks and Bristol Stool Scale, IBS-Visual Analogue Scale, IBS-Symptom Severity Score Scale (IBS-SSS), IBS-Quality of Life Scale (IBS-QoL) and Beck Depression Scale were administered to the participants at the beginning, 1st month and 2nd month. SPSS software programme was used for statistical analysis of the data. It is thought that inulin supplementation may be effective in reducing symptom severity and frequency, improving bowel function (stool frequency, consistency and transit time) and quality of life, and thus may be beneficial in individuals with constipation-predominant IBS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the treatment of IBS, a multimodel perspective that includes psychological support (cognitive behavioural therapy, stress management techniques, etc.) in addition to lifestyle changes (dietary changes, etc.) may be beneficial.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mardin, Turkey, 47200
        • Mardin Artuklu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • the individuals were between 19-65 years of age
  • volunteer to participate in the study
  • Individuals diagnosed with IBS by a physician according to Rome IV criteria

Exclusion Criteria:

  • a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
  • inflammatory bowel disease
  • lactose malabsorption
  • gastroenteritis
  • celiac disease
  • gastric
  • duodenal ulcer
  • metabolic diseases (cardiac, hepatic and renal diseases, diabetes, etc.)
  • history of malignancy
  • pregnancy and lactation
  • use of intestinal motility
  • antidepressant drugs
  • involuntary body weight loss of more than 5 kg in the last 3 months
  • use of dietary fibre supplements in the last 3 months
  • use of antibiotics in the last 3 months
  • use of prebiotic and probiotic supplements in the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prebiotic group
products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.
Dietary supplement: Prebiotic group
products containing a total of 9.2 g (4.6 g twice a day) inulin/oligofructose (50/50) mixture (prebiotic group) that individuals should consume daily were delivered to individuals in identical opaque bags.
Placebo Comparator: Placebo
products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags
Dietary supplement: Maltodextrin (Placebo)
products containing a total of 9.2 g (4.6 g twice a day) maltodextrin (placebo group) that individuals should consume daily were delivered to individuals in identical opaque bags.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS-Visual Analogue Scale (IBS-VAS)
Time Frame: 8 weeks
The scale, which consists of ten questions in total, is preferred for converting non-numerical values into numerical form. In this scale, the parameter to be evaluated is defined at both ends of a 100 mm line and there are cuts that will enable scoring from 1 to 10. The scoring on the scale indicates that 1:very bad, 10:very good.
8 weeks
The Irritable Bowel Syndrome Symptom Severity Score (IBS/SSS)
Time Frame: 8 weeks
The Irritable Bowel Syndrome Symptom Severity Score (IBS/SSS) was developed by Francis et al. (1997) to assess the severity of gastrointestinal symptoms in individuals with IBS. It consists of 5 questions in total and each question is scored between 0-100. The IBS-SSS scale has a maximum score of 500 points, which is classed as '75-174 points= mild IBS', '175-299 points= moderate IBS', and '>300 points= severe IBS'.
8 weeks
Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL)
Time Frame: 8 weeks
The quality of life levels were assessed using the Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL). The Irritable Bowel Syndrome Quality of Life Scale developed by Patrick et al. (1998) is divided into 8 sub-parametres, 34 questions in total and the lowest score is 34, while the highest score is 170. The increase in the total score obtained from the scale indicates a decrease in the quality of life associated with the disease.
8 weeks
The Bristol Stool Scale
Time Frame: 8 weeks
The Bristol Stool Scale was used to determine the type of IBS through stool forms. This scale aims to predict the stool form over 7 different stool forms. Constipation- predominant IBS was evaluated over the first 4 stool forms, and it is understood that there is an improvement as the stool forms of the individuals approach the type 4 form.
8 weeks
The Beck Depression Scale
Time Frame: 8 weeks
The Beck Depression Scale was used to evaluate the depression status of the individuals. It is a 21-question (multiple-choice) self-report scale developed by Aaron T. Beck to provide a quantitative assessment of depression severity (Beck, 1961). It provides a four-point Likert-type measurement. The score scale ranges from 0-3 for each question. Total score varies between 0-63. Higher scores obtained from the scale indicate more depressive symptoms. According to the validity and reliability article of the scale for Turkish, it was stated that the cut-off score was accepted as 17. In this study, the data were divided into two groups as depressed and non-depressed according to the scale using a cut-off score of 17.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mardin Artuklu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2021

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 20, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 377

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will not be shared because it contains personal information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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