Constipation - FunctionalNCT05429333
Effect of Microbiome Modulation by Diet in Functional Constipation
A study testing Artificial intelligence-assisted personalized diet in people with Constipation - Functional, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Artificial intelligence-assisted personalized diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2020to 27 Dec 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients fulfilling Rome IV criteria for functional constipation (FC)
- Patients who had a colonoscopy performed within the last 5 years
- Patients who had a colonic transit time assessment within the last 3 months
- Patients who had a magnetic resonance defecography within the last 3 months
Who cannot join
- Use of antibiotics, probiotics, and/or prebiotics within the last 4 weeks
- Gastrointestinal endoscopy within the last 4 weeks
- Major gastrointestinal surgery (total/segmental gastrectomy, small bowel and/or colonic resection)
- Cholecystectomy
- Inflammatory bowel diseases
- Celiac disease
- Any etiology of chronic constipation other than FC (irritable bowel syndrome, rectocele, dyssynergic defecation, opioid use)
- Endocrine, metabolic or neurologic disorders causing constipation (hypothyroidism, Parkinson's disease, paraplegia)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol University Esenler Hospital
Istanbul, Other (Non U.s.), 34230
About this study
Official title: Effect of Artificial Intelligence-assisted Personalized Microbiome Modulation by Diet in Functional Constipation: a Randomized Controlled Trial
Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. patients fulfilling Rome IV criteria for functional constipation were randomized into two groups. The Control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.
- Conditions
- Constipation - Functional
- Being tested
- Artificial intelligence-assisted personalized diet
- Keywords
- Microbiome, Artificial intelligence, Diet, Functional bowel disorders, Brain-gut diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence-assisted personalized dietOther
The AI-based nutritional recommendations system is based on the eating rates of the individual in a certain period, to ensure the homeostasis of the microbiome and increase the microbial diversity.
After the microbiome analysis reports of the study group are released, a 6-week diet was designed regarding AI-based food scores specific to constipated individuals in accordance with the individual's lifestyle and comorbidities. Diet lists are updated according to the individual's feedback, recovery level, and wishes with weekly meetings.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | After randomization control group was recommended to continue their regular diet with increased fluid (2 lt/day) and fiber intake (30 g/day) and received 5 mg of sodium picosulfate daily for 10 weeks. |
| Treatment group | Experimental | In the study group, after fecal samples were taken, patients were recommended to continue their regular diet with increased fluid (2 lt/day) and fiber intake (30 g/day) for 4 weeks until the microbiome analysis resulted. During subsequent 6 weeks, they received the personalized microbiome modulatory diet. Receives: Other: Artificial intelligence-assisted personalized diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three or more complete bowel movements per week at 10 weeks
The proportion of patients with a mean of three or more complete bowel movements per week (CBMpW) at 10 weeks is compared between control and study groups.
Measured: 10 weeks
Improvement in Patient Assessment Constipation Quality of Life
The proportion of the patients with more than 50% improvement in total Patient Assessment Constipation Quality of Life score is compared between control and study groups.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start14 Dec 2020
- Primary completion27 Dec 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429333
- Sponsor's protocol ID
- 10840098-772.02-E.47859
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence-assisted Personalized Microbiome Modulation by Diet in Functional Constipation: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05429333
- Acronym / sponsor ID
- 10840098-772.02-E.47859
- Conditions
- Constipation - Functional
- Keywords
- Microbiome, Artificial intelligence, Diet, Functional bowel disorders, Brain-gut diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 27 Dec 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 23 Jun 2022 (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.
Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. patients fulfilling Rome IV criteria for functional constipation were randomized into two groups. The Control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –After randomization control group was recommended to continue their regular diet with increased fluid (2 lt/day) and fiber intake (30 g/day) and received 5 mg of sodium picosulfate daily for 10 weeks. |
| Treatment group | Experimental | Other: Artificial intelligence-assisted personalized dietIn the study group, after fecal samples were taken, patients were recommended to continue their regular diet with increased fluid (2 lt/day) and fiber intake (30 g/day) for 4 weeks until the microbiome analysis resulted. During subsequent 6 weeks, they received the personalized microbiome modulatory diet. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients fulfilling Rome IV criteria for functional constipation (FC)
- Patients who had a colonoscopy performed within the last 5 years
- Patients who had a colonic transit time assessment within the last 3 months
- Patients who had a magnetic resonance defecography within the last 3 months
Key exclusion criteria (8 listed)
- Use of antibiotics, probiotics, and/or prebiotics within the last 4 weeks
- Gastrointestinal endoscopy within the last 4 weeks
- Major gastrointestinal surgery (total/segmental gastrectomy, small bowel and/or colonic resection)
- Cholecystectomy
- Inflammatory bowel diseases
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 |
|---|---|---|
| Artificial intelligence-assisted personalized dietThe AI-based nutritional recommendations system is based on the eating rates of the individual in a certain period, to ensure the homeostasis of the microbiome and increase the microbial diversity. After the microbiome analysis reports of the study group are released, a 6-week diet was designed regarding AI-based food scores specific to constipated individuals in accordance with the individual's lifestyle and comorbidities. Diet lists are updated according to the individual's feedback, recovery level, and wishes with weekly meetings. | Other | Treatment group |
Primary outcome
Three or more complete bowel movements per week at 10 weeks
Time frame: 10 weeks
The proportion of patients with a mean of three or more complete bowel movements per week (CBMpW) at 10 weeks is compared between control and study groups.
Improvement in Patient Assessment Constipation Quality of Life
Time frame: 10 weeks
The proportion of the patients with more than 50% improvement in total Patient Assessment Constipation Quality of Life score is compared between control and study groups.
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 23 Jun 2022.
- Individual participant dataSharing planned: Undecided
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Functional Constipation (FC)
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 Artificial intelligence-assisted personalized diet in people with Constipation - Functional, run by Istanbul Medipol University 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 8 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 23 Jun 2022. 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?
Three or more complete bowel movements per week at 10 weeks (time frame: 10 weeks). The study lists 2 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 23 Jun 2022.