Effectiveness of Low FODMAPs Diet Compared With Standard Dietary Advice in Functional Dyspepsia
NCT07925073, Not applicable, Recruiting, King Chulalongkorn Memorial Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effectiveness of Low FODMAPs Diet Compared With Standard Dietary Advice in Functional Dyspepsia | ClinicalTrials.gov |
| NCT number | NCT07925073 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | King Chulalongkorn Memorial Hospital | ClinicalTrials.gov |
| Conditions | Functional Dyspepsia | ClinicalTrials.gov |
| Interventions | Low Fodmap dietary advice, Standard dietary advice | ClinicalTrials.gov |
| First posted | 2026-11-09 | ClinicalTrials.gov |
| Last updated | 2026-11-09 | ClinicalTrials.gov |
Registered outcomes 4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) score | 2 weeks | The severity of functional dyspepsia symptoms will be assessed using the Patient Assessment of Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM), which consists of 20 items scored on a 6-point Likert scale from 0 (none) to 5 (very severe). The total score ranges from 0 to 5 when calculated as the mean of the item scores, with higher scores indicating greater symptom severity and worse outcomes. The change in mean symptom score from baseline to the end of the 2-week intervention will be compared between the low-FODMAP and standard dietary advice groups. Minimum score is 0, maximum score is 80 | ClinicalTrials.gov |
| Secondary | Change in the Number of High-FODMAP Food Items Consumed | 2 weeks | Change in the number of high-FODMAP food items consumed, assessed by reviewing participants' food diaries and counting reported high-FODMAP food items at baseline and during the intervention. The change from baseline to the end of the 2-week intervention will be compared between the low-FODMAP and standard dietary advice groups. | ClinicalTrials.gov |
| Secondary | Change in Stool Consistency and Bowel Habits Assessed by Daily Bowel Diary | 2 weeks | Change in stool consistency measured using the Bristol Stool Form Scale (BSFS), a 7-point scale ranging from 1 (separate hard lumps) to 7 (watery stool). Higher scores indicate looser stool consistency (worse outcome in terms of stool consistency). Bowel habits, including bowel movement frequency, will be assessed separately using the daily bowel diary. | ClinicalTrials.gov |
| Secondary | Change in Health-Related Quality of Life Assessed by the EQ-5D-5L | 2 weeks | Change in health-related quality of life from baseline to Week 2, assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. The EQ-5D-5L descriptive system assesses five dimensions of health, each with five response levels. The EQ-5D-5L index value will be calculated using the appropriate value set, with higher index values indicating better health-related quality of life. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)