Irritable Bowel Syndrome-IBSNCT06421922
Effect of Different Dietary Therapies on Intestinal Barrier Integrity in Patients With Irritable Bowel Syndrome
A study testing Group 1 received a regular constipation diet, Group 2 received a constipation diet rich in soluble fiber and Group 3 received a constipation diet supplemented with probiotic yogurt. in people with Irritable Bowel Syndrome-IBS, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
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). Read more about this study
- Who is it for?
- Ages 19 to 50 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome-IBS
- What is being tested?
- Group 1 received a regular constipation diet, Group 2 received a constipation diet rich in soluble fiber and Group 3 received a constipation diet supplemented with probiotic yogurt.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 7 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Chronic disease history such as cancer and autoimmune diseases
- Probiotics use or nutritional supplement use (vitamins, minerals) in the last 6 months.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome-IBS
- Being tested
- Group 1 received a regular constipation diet, Group 2 received a constipation diet rich in soluble fiber, Group 3 received a constipation diet supplemented with probiotic yogurt.
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 received a regular constipation dietDietary supplement
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.
Group 2 received a constipation diet rich in soluble fiberDietary supplement
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.
Group 3 received a constipation diet supplemented with probiotic yogurt.Dietary supplement
"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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1-regular constipation diet | Active comparator | Group 1 received a regular constipation diet (n=21) Receives: Dietary Supplement: Group 1 received a regular constipation diet |
| Group 2-soluble fiber | Active comparator | group 2 received a constipation diet rich in soluble fiber (n=17) Receives: Dietary Supplement: Group 2 received a constipation diet rich in soluble fiber |
| Group 3-probiotic yogurt | Active comparator | group 3 received a constipation diet with added probiotic yogurt (n=22). Receives: Dietary Supplement: Group 3 received a constipation diet supplemented with probiotic yogurt. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Zonulin level
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.
Measured: 0-8 weeks
Secondary outcomes (1)
Other biomarkers (fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP)
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.
Measured: 0-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jun 2019
- Primary completion15 Oct 2019
- Study completion7 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome-IBSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emine Nuket Unsal, Gulhane Training and Research Hospital
- Investigators
- Emine Nuket Unsal, Phd, Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421922
- Sponsor's protocol ID
- 50687469-799
- Other IDs
- 50687469-799
- Status last verified
- May 2024
- First submitted
- 8 May 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06421922
- Acronym / sponsor ID
- 50687469-799
- Conditions
- Irritable Bowel Syndrome-IBS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 7 Jun 2020 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1-regular constipation diet | Active comparator | Dietary Supplement: Group 1 received a regular constipation dietGroup 1 received a regular constipation diet (n=21) |
| Group 2-soluble fiber | Active comparator | Dietary Supplement: Group 2 received a constipation diet rich in soluble fibergroup 2 received a constipation diet rich in soluble fiber (n=17) |
| Group 3-probiotic yogurt | Active comparator | Dietary Supplement: Group 3 received a constipation diet supplemented with probiotic yogurt.group 3 received a constipation diet with added probiotic yogurt (n=22). |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Chronic disease history such as cancer and autoimmune diseases
- Probiotics use or nutritional supplement use (vitamins, minerals) in the last 6 months.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 1 received a regular constipation dietGroup 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. | Dietary supplement | Group 1-regular constipation diet |
| Group 2 received a constipation diet rich in soluble fiberSoluble 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. | Dietary supplement | Group 2-soluble fiber |
| Group 3 received a constipation diet supplemented with probiotic yogurt."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. | Dietary supplement | Group 3-probiotic yogurt |
Primary outcome
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.
1 secondary outcome
Other biomarkers (fasting blood glucose, cholesterol, blood triglyceride, LDL cholesterol and CRP)
Time frame: 0-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome-IBS
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emine Nuket Unsal, Phd principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 received a regular constipation diet, Group 2 received a constipation diet rich in soluble fiber and Group 3 received a constipation diet supplemented with probiotic yogurt. in people with Irritable Bowel Syndrome-IBS, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Zonulin level (time frame: 0-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.