- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421922
Effect of Different Dietary Therapies on Intestinal Barrier Integrity in Patients With Irritable Bowel Syndrome
The Effects of Supplementation of Diet With Fiber or Probiotic Yogurt on the Intestinal Barrier Integrity in Individuals With Constipation-predominant Irritable Bowel Syndrome
Study Overview
Status
Conditions
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 G*Power software. With an estimated power of 90%, a Type I error of 0.05, and an effect size of f=0.25, the total sample size required was 54, consisting of 18 participants in each group. The sample size was calculated using G*Power software. The total sample size, with an estimated strength of 90%, Type I error of 0.05, and effect size f = 0.25, 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 2's constipation diet included 1 sachet of soluble fiber (resistant starch) (5 g/day), and in the second week, 2 sachets of soluble fiber (10 g/day) 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 22.00 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 p<0.05 was determined.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Keçiören
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Ankara, Keçiören, Turkey, 06010
- GulhaneTRH
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Women aged 19-50 years who were diagnosed with IBS according to Rome IV criteria
- Any metabolic disease (diabetes, heart disease, etc.), cancer and autoimmune no history of chronic diseases such as illness
- Not being pregnant or lactating
- Body mass index (BMI) of 18.5-29.9 kg/m2
Exclusion Criteria:
- Chronic disease history such as cancer and autoimmune diseases
- Probiotics use or nutritional supplement use (vitamins, minerals) in the last 6 months.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1-regular constipation diet
Group 1 received a regular constipation diet (n=21)
|
Group 1 received only regular constipation diet, the constipation diet included 2 litres of water, 2 portions of vegetables, 3 portions of fruits and legumes 2 times a week.
Followed 8 weeks.
|
Active Comparator: Group 2-soluble fiber
group 2 received a constipation diet rich in soluble fiber (n=17)
|
Soluble fiber (resistant starch) (5 g/day) was added to the constipation diet in group 2 as 1 sachet/day (5 g/day) during the initial 4 weeks and 2 sachets/day (10 g/day) in the following 4 weeks.
|
Active Comparator: Group 3-probiotic yogurt
group 3 received a constipation diet with added probiotic yogurt (n=22).
|
"Bifidobacterium İnfantis 35624 (B.
İnfantis 35624)" strain, which is specific to IBS, was added to yogurt in group 3, consumed before the lunch.
The follow-up period was 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum Zonulin level
Time Frame: 0-8 weeks
|
The primary outcome was the change in blood Zonulin level after adding probiotic yogurt to a regular constipation diet instead of soluble fiber.
Serum zonulin levels were analysed to evaluate the effect of dietary compliance on intestinal barrier integrity.
Lower serum zonulin levels indicate a better intestinal barrier integrity.
|
0-8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Other biomarkers (fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP)
Time Frame: 0-8 weeks
|
The secondary outcomes were changes in fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP levels after adding probiotic yogurt to a regular constipation diet instead of soluble fiber.
|
0-8 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Emine Nuket Unsal, Phd, Gulhane Training and Research Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 50687469-799 (Other Grant/Funding Number: TUEK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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