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Completed

NCT Number: NCT05656391

Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis in Remission

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Doctor Josep Trueta

Girona, Catalonia, 17007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Treatment vs control bread

Dietary Supplement

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

Primary outcomes

  1. Changes in IBS-like symptomatology

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

    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.

Secondary outcomes

  1. Changes in the abundance of bacterial markers

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

    Shifts of abundance of Eubacteria (EUB), A. municiphila (AKK), M. smithii (MSM), Bacteroidetes (BAC), Ruminococcus sp. (RUM), F. prausnitzii (FPRA) and E. coli (ECO) levels will be measured prior (T0) and after the intervention (T1). Results will be expressed as 16S gene copies of microbes per gram of faeces

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Registry information

Official study title

Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 19, 2022
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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