Irritable Bowel Syndrome MixedNCT04768387
The Effect of AI-based Microbiome Diet on IBS-M Symptoms
A study testing Personalized microbiome diet in people with Irritable Bowel Syndrome Mixed, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome Mixed
- What is being tested?
- Personalized microbiome diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2020to 15 Jan 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with IBS by a medical doctor.
- BMI between 18.5-39.9 kg/m2
- No hospitalization in the last 12 months.
- No antibiotics use in the last 6 months.
- No cancer diagnosis by a medical doctor.
- No chronic complex diseases including diabetes and hypertension.
Who cannot join
- Not being diagnosed with IBS.
- Having a diagnosed chronic disease.
- Having a diagnosed mental or psychiatric disorder .
- Having endocrinal disorders.
- Being pregnant.
- Antibiotics use in the last 6 months.
Show all 9Show fewer
- Hospitalization history in the last 12 months.
- Drug use.
- Being morbid obese.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-labelled Interventional Study With 25 IBS-M Patients in Which Group 1 (n=14) Followed Six Weeks of AI-based Microbiome Diet and Group 2 (n=11) Followed Standard IBS Diet
This study was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Patients were divided into two groups based on age, gender and microbiome matched.
Six weeks of AI-based microbiome diet (n=14) for group 1 and standard IBS diet (Control group, n=11) for group 2 were followed. AI-based diet was designed based on optimizing a personalized nutritional strategy by an algorithm regarding individual gut microbiome features. An algorithm assessing an IBS index score using microbiome composition attempted to design the optimized diets based on modulating microbiome towards the healthy scores. Baseline and post-intervention IBS-SSS (symptom severity scale) scores and fecal microbiome analyses were compared.
- Conditions
- Irritable Bowel Syndrome Mixed
- Being tested
- Personalized microbiome diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized microbiome dietDietary supplement
Also called ARTIFICIAL INTELLIGENCE BASED PERSONALIZED DIET
The personalized nutrition model estimates the optimal micronutrient compositions for a required microbiome modulation. In this study, we computed the microbiome modulation needed for an IBS case, based on the IBS-indices generated by the machine learning models. According to that, the baseline microbiome compositions are perturbed randomly with a small probability p. Perturbed profiles are accepted with a probability proportional to the decrease in the IBS-index as suggested by Metropolis sampling. This Monte-Carlo random walk in the microbiome composition space is expected to meet a low IBS-index microbiome composition nearby the baseline microbiome composition of the patient with a minimal modulation. The personalized nutrition model, then, estimates the optimized nutritional composition needed for this individual, expecting to drive the IBS-index to lower values.
| Study group | Role | What they receive |
|---|---|---|
| Personalized microbiome diet | Experimental | Six weeks of AI-based microbiome diet was introduced. Receives: Dietary Supplement: Personalized microbiome diet |
| Standard IBS diet | Active comparator | Six weeks of standard IBS diet was introduced. Receives: Dietary Supplement: Personalized microbiome diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS-SSS change
Change in IBS-SSS scores according to ROME IV criteria were assessed.
Measured: Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start5 Oct 2020
- Primary completion16 Nov 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome MixedStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Collaborators
- ENBIOSIS BIOTECHNOLOGIES, TC Erciyes University
- Responsible party
- Principal investigator, Tarkan Karakan, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768387
- Sponsor's protocol ID
- EnbiosisIBS
- Status last verified
- Feb 2021
- First submitted
- 19 Feb 2021
- Last updated
- 24 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labelled Interventional Study With 25 IBS-M Patients in Which Group 1 (n=14) Followed Six Weeks of AI-based Microbiome Diet and Group 2 (n=11) Followed Standard IBS Diet
- ClinicalTrials.gov ID
- NCT04768387
- Acronym / sponsor ID
- EnbiosisIBS
- Conditions
- Irritable Bowel Syndrome Mixed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Collaborators
- ENBIOSIS BIOTECHNOLOGIES, TC Erciyes University
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 24 Feb 2021 (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 was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Patients were divided into two groups based on age, gender and microbiome matched.
Six weeks of AI-based microbiome diet (n=14) for group 1 and standard IBS diet (Control group, n=11) for group 2 were followed. AI-based diet was designed based on optimizing a personalized nutritional strategy by an algorithm regarding individual gut microbiome features. An algorithm assessing an IBS index score using microbiome composition attempted to design the optimized diets based on modulating microbiome towards the healthy scores. Baseline and post-intervention IBS-SSS (symptom severity scale) scores and fecal microbiome analyses were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized microbiome diet | Experimental | Dietary Supplement: Personalized microbiome dietSix weeks of AI-based microbiome diet was introduced. |
| Standard IBS diet | Active comparator | Dietary Supplement: Personalized microbiome dietSix weeks of standard IBS diet was introduced. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with IBS by a medical doctor.
- BMI between 18.5-39.9 kg/m2
- No hospitalization in the last 12 months.
- No antibiotics use in the last 6 months.
- No cancer diagnosis by a medical doctor.
Key exclusion criteria (9 listed)
- Not being diagnosed with IBS.
- Having a diagnosed chronic disease.
- Having a diagnosed mental or psychiatric disorder .
- Having endocrinal disorders.
- Being pregnant.
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 |
|---|---|---|
| Personalized microbiome dietAlso: ARTIFICIAL INTELLIGENCE BASED PERSONALIZED DIETThe personalized nutrition model estimates the optimal micronutrient compositions for a required microbiome modulation. In this study, we computed the microbiome modulation needed for an IBS case, based on the IBS-indices generated by the machine learning models. According to that, the baseline microbiome compositions are perturbed randomly with a small probability p. Perturbed profiles are accepted with a probability proportional to the decrease in the IBS-index as suggested by Metropolis sampling. This Monte-Carlo random walk in the microbiome composition space is expected to meet a low IBS-index microbiome composition nearby the baseline microbiome composition of the patient with a minimal modulation. The personalized nutrition model, then, estimates the optimized nutritional composition needed for this individual, expecting to drive the IBS-index to lower values. | Dietary supplement | Personalized microbiome diet, Standard IBS diet |
Primary outcome
IBS-SSS change
Time frame: Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts
Change in IBS-SSS scores according to ROME IV criteria were assessed.
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 Feb 2021.
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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 Personalized microbiome diet in people with Irritable Bowel Syndrome Mixed, run by Gazi 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 6 inclusion and 9 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 Feb 2021. 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?
IBS-SSS change (time frame: Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts). 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 Feb 2021.