NCT05148039

Brief Summary

This study involves a comprehensive nutritional assessment of hEDS participants who have functional gastrointestinal disorders and dietary intervention to broaden their food choices and nutritional intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

November 16, 2021

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 7, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

November 16, 2021

Last Update Submit

August 4, 2023

Conditions

Hypermobile Ehlers-Danlos SyndromeIrritable Bowel SyndromeFunctional Gastrointestinal Disorders

Keywords

NutritionDiet

Outcome Measures

Primary Outcomes (1)

  • Number of patients

    Number of patients who adhere to dietary recommendations based on acceptability of intervention and ease of delivery.

    3 months

Secondary Outcomes (8)

  • United Kingdom Diet Quality Index as calculated by the Scottish Collaborative Group Food Frequency Questionnaire (SCG FFQ)

    3 months

  • Gastrointestinal Symptom Rating Scale (GSRS)

    3 months

  • Hospital Anxiety and Depression Scale (HADS)

    3 months

  • Visceral Sensitivity Index (VSI)

    3 months

  • Patient Health Questionnaire-15 (PHQ-15)

    3 months

  • +3 more secondary outcomes

Study Arms (2)

Community cohort

ACTIVE COMPARATOR

Participants from the Ehlers Danlos UK society community who low diet quality

Behavioral: Dietician advice

Clinic cohort

ACTIVE COMPARATOR

Participants from a Tertiary Neurogastroenterology clinic who have low die quality

Behavioral: Dietician advice

Interventions

Dietician adviceBEHAVIORAL

Personalised dietetic advice

Clinic cohortCommunity cohort

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Have completed Phase I of the CANDI-hEDS study
  • Diagnosis of hEDS / HSD according to physical examination and history taking
  • Diagnosis of Functional Dyspepsia and / or Irritable Bowel Syndrome according to Rome IV criteria
  • Able and willing to give informed consent
  • Access to video conferencing and a smart phone device
  • Able to travel to the Wingate Institute

You may not qualify if:

  • Dependent upon artificial feeding (parenteral and enteral)
  • Structural gastrointestinal disease
  • Any chronic health condition which already requires a restricted diet e.g. diabetes mellitus
  • Functional vomiting disorder with associated weight loss
  • Multiple Type I hypersensitivity reactions to food groups (i.e. anaphylaxis, urticaria, respiratory symptoms or positive RAST tests).
  • Previous or current severe mental health disorder (e.g. severe depression with suicidal ideation)
  • Previous or current eating disorder
  • Positive screen for avoidant restrictive food intake disorder (ARFID)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Queen Marys University London

London, United Kingdom

Location

MeSH Terms

Conditions

Ehlers-Danlos syndrome type 3Irritable Bowel SyndromeGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Tertiary clinic versus a selective community cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2021

First Posted

December 8, 2021

Study Start

April 7, 2022

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

GB(1)