Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06421922 |
| Other study ID # |
50687469-799 |
| Secondary ID |
50687469-799 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2019 |
| Est. completion date |
June 7, 2020 |
Study information
| Verified date |
May 2024 |
| Source |
Gulhane Training and Research Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
Hospital's 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.
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.
