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Trial · NCT07888998

Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients

NCT07888998, Not applicable, Active not recruiting, Acibadem University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients. Trials, record NCT07888998. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07888998

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Evaluation of the Effect of a Low-FODMAP Diet on Gastrointestinal Symptoms and Inflammatory Markers in Fabry Patients
NCT number
NCT07888998
Status
Active not recruiting
Phases
Not applicable
Enrollment
30 participants, estimated
Lead sponsor
Acibadem University
Conditions
Fabry Disease
Interventions
Low-FODMAP Diet
First posted
2026-10-22
Last updated
2026-10-26

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Gastrointestinal Symptom Rating Scale (GSRS) ScoreBaseline and Week 6
Gastrointestinal symptoms will be evaluated using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS assesses gastrointestinal symptoms across five domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is scored on a seven-point Likert scale, with higher scores indicating more severe gastrointestinal symptoms. Changes in GSRS scores from baseline to week 6 will be compared between the intervention and control groups.
PrimaryChange in Plasma Neopterin LevelsBaseline and Week 6Neopterin levels will be measured at baseline and after six weeks to evaluate changes in inflammatory status. Changes from baseline will be compared between the intervention and control groups.
PrimaryChange in Interleukin-6 (IL-6) LevelsBaseline and Week 6
Interleukin-6 (IL-6) concentrations will be measured at baseline and after six weeks to evaluate changes in systemic inflammation following the dietary intervention. Changes in IL-6 concentrations from baseline to week 6 will be compared between the low-FODMAP diet and control groups.
PrimaryChange in Tumor Necrosis Factor-alpha (TNF-α) LevelsBaseline and Week 6
Tumor necrosis factor-alpha (TNF-α) concentrations will be measured at baseline and after six weeks to evaluate changes in systemic inflammation following the dietary intervention. Changes in TNF-α concentrations from baseline to week 6 will be compared between the low-FODMAP diet and control groups.
PrimaryChange in Plasma Biopterin LevelsBaseline and Week 6Biopterin levels will be measured at baseline and after six weeks. Changes from baseline will be compared between the intervention and control groups.
SecondaryChange in Short Form-36 (SF-36) Health Survey ScoresBaseline and Week 6
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire evaluates eight domains of physical and mental health. Domain scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes from baseline to week 6 will be compared between the intervention and control groups.
SecondaryChange in Bristol Stool Form Scale ClassificationBaseline and Week 6
Stool consistency will be assessed using the Bristol Stool Form Scale, which categorizes stool characteristics into seven types (Type 1-7). Changes in stool characteristics between baseline and week 6 will be evaluated.
SecondaryChange in Lyso-Globotriaosylceramide (Lyso-Gb3) LevelsBaseline and Week 6Lyso-globotriaosylceramide (Lyso-Gb3) concentrations will be measured at baseline and after six weeks. Changes from baseline will be compared between the intervention and control groups.

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.

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
29202473BACKGROUNDPubMed
35090382BACKGROUNDPubMed
36771363BACKGROUNDPubMed

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT07888998

GET https://conductscience.org/api/trials/v1/NCT07888998/registered