Trial · NCT07901972
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
NCT07901972, Not applicable, Not yet recruiting, University Hospital of Patras
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD). Trials, record NCT07901972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07901972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
- NCT number
- NCT07901972
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 108 participants, estimated
- Lead sponsor
- University Hospital of Patras
- Conditions
- Irritable Bowel Syndrome
- Interventions
- Mediterranean Standard Diet, Mediterranean Modified Low FODMAP Diet
- First posted
- 2026-10-28
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in symptom severity from baseline to post-intervention, assessed using a validated disease-specific questionnaire. | Baseline, 6 Weeks and 6 months | The Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) consists of five items, each accompanied by specific scoring instructions. The five items assess pain severity, pain frequency, severity of abdominal distension, satisfaction with bowel habits, and the impact of IBS on quality of life. Each item is scored from 0 to 100 using a visual analogue scale (VAS), yielding a total score ranging from 0 to 500, with higher scores indicating greater symptom severity. Patients may be classified as having mild (75-175), moderate (175-300), or severe (\>300) IBS. A reduction of 50 points is considered clinically meaningful. |
| Secondary | Assessment of IBS-related quality of life using a disease-specific questionnaire before and after the intervention, with comparisons between the study groups. | Baseline, 6 weeks and 6 months | The Irritable Bowel Syndrome Quality of Life (IBS-QOL) is a self-reported, disease-specific measure that assesses the extent to which IBS has affected patients' quality of life during the previous 30 days. It includes eight domains: dysphoria, interference with activity, body image, health worry, food avoidance, social reactions, sexual concerns, and relationships. Each item is rated on a 5-point Likert scale, with higher scores indicating poorer quality of life. The total raw score ranges from 34 to 170. A reduction of at least 10 points is considered a clinically meaningful improvement. |
| Secondary | Bristol Stool Form Scale (BSFS), Type 1-7 | baseline, 6 weeks and 6 months | Stool consistency will be assessed using the Bristol Stool Form Scale, a 7-point categorical scale ranging from Type 1 (separate hard lumps) to Type 7 (watery stool with no solid pieces). Higher scores indicate progressively softer and looser stool consistency. Because both ends of the scale represent abnormal consistency - Types 1-2 indicating hard stool/constipation and Types 6-7 indicating loose/watery stool/diarrhea - the scale is not unidirectional, and neither a higher nor a lower score represents a uniformly better or worse outcome. Types 3-4 represent normal stool consistency and are generally considered the optimal range. |
| Secondary | Assessment of anxiety and depressive symptoms before and after the intervention. | Baseline, 6 weeks and 6 months | The Hospital Anxiety and Depression Scale (HADS) is used to assess symptoms of anxiety and depression. It comprises 14 items divided into two seven-item subscales: anxiety (HADS-A) and depression (HADS-D). Each item is rated on a 4-point response scale ranging from 0 to 3. The score for each subscale is calculated by summing the corresponding seven items and ranges from 0 to 21. A score of 0-7 indicates no clinically relevant symptoms, 8-10 indicates mild symptoms, and a score of ≥11 indicates more severe symptoms of anxiety or depression. |
| Secondary | Mediterranean Diet Adherence Score | Baseline, 6 weeks and 6 months | The Mediterranean Diet Adherence Screener (MEDAS) is a 14-item questionnaire used to assess adherence to the Mediterranean diet. The items evaluate the consumption of key components of the Mediterranean dietary pattern, including whole grains, fruits, vegetables, legumes, fish, meat and meat products, poultry, full-fat dairy products, sweets, olive oil, and alcohol. The total MEDAS score ranges from 0 to 14, with higher scores indicating greater adherence. Adherence is classified as low (≤5), moderate (6-9), or high (≥10). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07901972
GET https://conductscience.org/api/trials/v1/NCT07901972/registered