Bowel SymptomsNCT06610188
The Effect of Inulin in Irritable Bowel Syndrome
A study testing Prebiotic group in people with Bowel Symptoms and Depression Disorders, run by Mardin Artuklu University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Symptoms, Depression Disorders, Inulin
- What is being tested?
- Prebiotic group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2021to 1 Apr 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
- inflammatory bowel disease
- lactose malabsorption
- gastroenteritis
- celiac disease
- gastric
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Bowel Symptoms, Depression Disorders, Inulin, Constipation, Quality of Life (QOL), Irritable Bowel Syndrome (IBS)
- Being tested
- Prebiotic group, Maltodextrin (Placebo)
- Keywords
- Bowel symptoms, depression, inulin, constipation-predominant IBS, quality of life
- Medical subject headings
- Constipation, Irritable Bowel Syndrome, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic groupDietary supplement
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.
Maltodextrin (Placebo)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic group | Experimental | 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. Receives: Dietary Supplement: Prebiotic group |
| Placebo | Placebo comparator | 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 Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-Visual Analogue Scale (IBS-VAS)
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.
Measured: 8 weeks
The Irritable Bowel Syndrome Symptom Severity Score (IBS/SSS)
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\'.
Measured: 8 weeks
Irritable Bowel Syndrome Quality of Life Scale (IBS-QoL)
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.
Measured: 8 weeks
The Bristol Stool Scale
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.
Measured: 8 weeks
The Beck Depression Scale
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start3 Nov 2021
- Primary completion3 Dec 2021
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel SymptomsStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Individuals were randomly assigned to one of two groups: prebiotic (n=17) and placebo (n=17) groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mardin Artuklu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çağlar Akçalı, Mardin Artuklu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610188
- Sponsor's protocol ID
- 377
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared because it contains personal information.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inulin on Intestinal Symptoms, Depression and Quality of Life in Individuals With Constipation-Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06610188
- Acronym / sponsor ID
- 377
- Conditions
- Bowel Symptoms, Depression Disorders, Inulin, Constipation, Quality of Life (QOL), Irritable Bowel Syndrome (IBS)
- Keywords
- Bowel symptoms, depression, inulin, constipation-predominant IBS, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mardin Artuklu UniversityUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 3 Dec 2021 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 24 Sep 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individuals were randomly assigned to one of two groups: prebiotic (n=17) and placebo (n=17) groups.
| Arm | Type | Receives |
|---|---|---|
| Prebiotic group | Experimental | Dietary Supplement: Prebiotic groupproducts 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 | Placebo comparator | 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 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- a history of gastrointestinal surgery (except appendectomy and cholecystectomy)
- inflammatory bowel disease
- lactose malabsorption
- gastroenteritis
- celiac disease
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 |
|---|---|---|
| Prebiotic groupproducts 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 |
| 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. | Dietary supplement | Placebo |
Primary outcome
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.
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\'.
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.
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.
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.
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 24 Sep 2024.
- Individual participant dataSharing planned: No. Data will not be shared because it contains personal information.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic group in people with Bowel Symptoms and Depression Disorders, run by Mardin Artuklu University 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 3 inclusion and 16 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 24 Sep 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. Some participants in this study may receive a placebo. 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?
IBS-Visual Analogue Scale (IBS-VAS) (time frame: 8 weeks). The study lists 5 primary outcomes in all. 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 24 Sep 2024.