NCT02946827

Brief Summary

FODMAPS (fructose, oligosaccharides, monosaccharides, disaccharides and polyols) are characterised as fermentable but poorly absorbed carbohydrates which enter the colon and are utilised by colonic bacteria. During fasting colonic nutrients are scarce but ingesting FODMAPS causes a rapid increase in carbohydrate which can overwhelm the microbiota's ability to utilise substrate. The excess reducing equivalents will generate hydrogen or methane. The principal symptoms are diarrhoea and abdominal distension. Patients with irritable bowel syndrome appear to benefit by restricting intake, possibly because they are hypersensitive to intestinal distension. The focus of the study is to evaluate if in celiac patients with persistent abdominal symptoms and with a correct gluten free diet, a low FODMAPs diet can improve their symptoms. Moreover the study would like to observe if a dietary restriction in FODMAPs carries the risk of nutritional inadequacy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 27, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

October 18, 2016

Last Update Submit

October 26, 2016

Conditions

Celiac Disease

Keywords

FODMAPs dietmicro-macro nutrients intakeIBS (Irritable Bowel Syndrome)

Outcome Measures

Primary Outcomes (1)

  • Improvement of VAS (psychometric response scale level continuous line between two end-points 0-10) values of globel well-being in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients in balanced gluten free diet.

    21 days

Secondary Outcomes (4)

  • Improvement of VAS values of IBS symptoms in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.

    21 days

  • Improvement of quality of life assessed through SF-36 questionnaire (eight scale scores) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.

    21 days

  • Improvement of psychological problems and symptoms of psychopathology through the symptom checklist 90 R (SCL 90 R) in patients undergoing a balanced Gluten Free/low FODMAPs diet compared to patients undergoing only a balanced gluten free diet.

    21 days

  • Evaluation of the dietary intake in micro and macro-nutrients before and after a Low FODMAP diet or a balanced Gluten Free diet through questionnaire.

    21 days

Study Arms (2)

Low FODMAPs /balanced gluten free diet

EXPERIMENTAL

An expert in nutrition will give a balanced gluten free diet to patients, low in FODMAPs foods.

Dietary Supplement: Balanced low FODMAPs /gluten free diet

Balanced gluten free diet

ACTIVE COMPARATOR

An expert in nutrition will give a balanced gluten free diet to patients.

Dietary Supplement: Balanced gluten free diet

Interventions

Balanced low FODMAPs /gluten free dietDIETARY_SUPPLEMENT
Low FODMAPs /balanced gluten free diet
Balanced gluten free dietDIETARY_SUPPLEMENT
Balanced gluten free diet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Celiac patients assessed through positive serology and histology
  • functional patients according IBS Roma III criteria
  • subjects with VAS\>5

You may not qualify if:

  • refractory celiac disease
  • disaccharide intolerance (fructose an lactose breath test)
  • abdominal surgery
  • comorbidity
  • patients recruited in other clinical trials
  • positive patients at lactulose breath test (SIBO)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Milan

Milan, Milan, 20122, Italy

RECRUITING

MeSH Terms

Conditions

Celiac DiseaseIrritable Bowel Syndrome

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesColonic Diseases, FunctionalColonic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Central Study Contacts

Leda Roncoroni, BS PhD

CONTACT

+39025503384leda.roncoroni@unimi.it

Leda Roncoroni

CONTACT

leda.roncoroni@unimi.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BS PhD

Study Record Dates

First Submitted

October 18, 2016

First Posted

October 27, 2016

Study Start

January 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

October 27, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)