Viewing Study NCT06421922



Ignite Creation Date: 2024-06-16 @ 11:48 AM
Last Modification Date: 2024-10-26 @ 3:30 PM
Study NCT ID: NCT06421922
Status: COMPLETED
Last Update Posted: 2024-05-22
First Post: 2024-05-08

Brief Title: Effect of Different Dietary Therapies on Intestinal Barrier Integrity in Patients With Irritable Bowel Syndrome
Sponsor: Gulhane Training and Research Hospital
Organization: Gulhane Training and Research Hospital

Study Overview

Official Title: The Effects of Supplementation of Diet With Fiber or Probiotic Yogurt on the Intestinal Barrier Integrity in Individuals With Constipation-predominant Irritable Bowel Syndrome
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study aims to evaluate the effects of different dietary treatments on intestinal integrity in female subjects aged 19-50 years previously diagnosed with constipation-predominant irritable bowel syndrome IBS At the Gülhane Training and Research Hospitals gastroenterology clinic in Ankara Turkey a randomized controlled experiment was carried out 60 individuals with IBS were randomly divided into three groups Group 1 was assigned to a regular constipation diet group 2 to a constipation diet rich in soluble fibers and group 3 to a constipation diet with probiotic yogurt supplementation Every individual was monitored for eight weeks Plasma zonulin level was used to measure intestinal integrity both before and after treatment
Detailed Description: This was a non-pharmacological randomized controlled trial conducted at Ankara Gülhane Training and Research Hospital Gastroenterology Polyclinic between June 2019 and March 2020 Participants of this study were women aged 19 to 50 years with a diagnosis of IBS according to the Rome IV criteria 2017

The sample size was calculated with GPower software With an estimated power of 90 a Type I error of 005 and an effect size of f025 the total sample size required was 54 consisting of 18 participants in each group The sample size was calculated using GPower software The total sample size with an estimated strength of 90 Type I error of 005 and effect size f 025 was 54 consisting of 18 participants in each group 60 participants were targeted due to compensation for potential drop-out from protocol

Using random assignment software participants were divided into three groups at random for parallel group randomized trials Group 1 received a standard constipation diet Group 2 received a soluble fiber-rich constipation diet and Group 3 received a probiotic yogurt-supplemented constipation diet The three groups-regular constipation diet constipation diet high in soluble fiber and constipation diet fortified with probiotic yogurt-were coded R 1-2 F 1-2 and P 1-2 to protect patient confidentiality Twice a week two liters of water two servings of vegetables and three servings of fruits and legumes were the staples of the constipation diet For the first four weeks Group 2s constipation diet included 1 sachet of soluble fiber resistant starch 5 gday and in the second week 2 sachets of soluble fiber 10 gday were added It happens after four weeks In Group 3 the yogurt ingested before lunch was supplemented with the IBS-specific strain Bifidobacterium Infantis 35624 B Infantis 35624 For eight weeks there was a follow-up

All data were collected by face-to-face survey method At the first visit sociodemographic characteristics and three-day food consumption were recorded Food consumption was recorded for 3 days 2 days on weekdays and 1 day on weekends Serum Zonulin level and biochemical tests were evaluated at the beginning of the diet and the 8th week Serum Zonulin level was measured using the BT Lab Human Zonulin ELISA Kit China E1117 Daily energy and nutrient amounts taken from the diet were analyzed using the Nutrition Information System 8 BeBis 8 computer package program

IBM SPSS Statistics 2200 program was used to analyze the data obtained The normal distribution of the data was evaluated with the Shapiro-Wilk test To increase clarity and ensure consistency with other studies continuous variables are presented as mean standard deviation Spearman rank correlation coefficients are a way to represent correlations between continuous variables Analysis of variance or the Kruskal Wallis test was used to compare groups Wilcoxon signed-rank test was used to compare groups within the same group from baseline to week eight The significance threshold of p005 was determined

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
50687469-799 OTHER_GRANT TUEK None