NCT05656391

Brief Summary

The present study aimed to compare the in vivo prebiotic properties of bread produced by traditional breadmaking techniques with that made using a modern breadmaking method on Irritable Bowel Syndrome-like symptoms in patients with quiescent Ulcerative Colitis. The expected outcome of the differential effects was a change in the faecal microbiome composition, which may indicate changes in the mucosa-associated microbiota.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

Study Start

First participant enrolled

December 16, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

1.7 years

First QC Date

December 1, 2022

Last Update Submit

December 18, 2022

Conditions

Ulcerative Colitis in Remission

Outcome Measures

Primary Outcomes (1)

  • Changes in IBS-like symptomatology

    Changes in IBS-like symptomatology were tested by IBS-Symptom Severity Score. The overall IBS-SSS score was calculated by totalling the punctuation of its five items. Each ranged from 0 to 100: (i) abdominal pain, (ii) number of days of abdominal pain during the last 10 days (number of days with abdominal pain x10), (ii) abdominal distension, (iv) satisfaction of defecatory behaviour, (v) interference of IBS symptoms in life. The possible range was then 0-500.

    Measurements were assessed at baseline (T0) and eight weeks (T1)

Secondary Outcomes (1)

  • Changes in the abundance of bacterial markers

    Measurements were assessed at baseline (T0) and eight weeks (T1)

Study Arms (2)

Treatment bread

ACTIVE COMPARATOR

Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques

Dietary Supplement: Treatment vs control bread

Control bread

PLACEBO COMPARATOR

Dietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques

Dietary Supplement: Treatment vs control bread

Interventions

Treatment vs control breadDIETARY_SUPPLEMENT

Consumption of 200 grams per day of either treatment or control bread for eight weeks

Control breadTreatment bread

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with ulcerative colitis according to established clinical and histological criteria as common clinical practice
  • Remission of ulcerative colitis defined as a total Mayo score ≤2 and faecal calprotectin values under 250 ng/g
  • Subjects aged over 18 years
  • Moderate-to-severe IBS-like symptomatology defined by Rome IV criteria and IBS Symptom Severity Score (IBS-SSS) \> 175.

You may not qualify if:

  • Presence of flare-up of UC
  • Coeliac disease, colectomy, or intestinal resection
  • Antibiotic intake, prebiotic or probiotic treatment within 3 months before the study
  • Any malignancy, pregnancy, or breastfeeding
  • Intake of medication potentially influencing gastrointestinal function
  • Disability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Location

Related Publications (1)

  • Lluansi A, Lliros M, Carreras-Torres R, Bahi A, Capdevila M, Feliu A, Vila-Quintana L, Elias-Masiques N, Cueva E, Peries L, Torrealba L, Miquel-Cusachs JO, Sabat M, Busquets D, Lopez C, Delgado-Aros S, Garcia-Gil LJ, Elias I, Aldeguer X. Impact of bread diet on intestinal dysbiosis and irritable bowel syndrome symptoms in quiescent ulcerative colitis: A pilot study. PLoS One. 2024 Feb 16;19(2):e0297836. doi: 10.1371/journal.pone.0297836. eCollection 2024.

    PMID: 38363772DERIVED

Study Officials

  • Xavier Aldeguer

    Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gastroenterology Department

Study Record Dates

First Submitted

December 1, 2022

First Posted

December 19, 2022

Study Start

December 16, 2019

Primary Completion

August 16, 2021

Study Completion

August 16, 2021

Last Updated

December 20, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)