Ulcerative Colitis in RemissionNCT05656391
Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis
A study of Ulcerative Colitis in Remission, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis in Remission
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSpain
- Study dates
- 16 Dec 2019to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study
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.
- Conditions
- Ulcerative Colitis in Remission
- Being tested
- Treatment vs control bread
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment vs control breadDietary supplement
Consumption of 200 grams per day of either treatment or control bread for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment bread | Active comparator | Dietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques Receives: 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 Receives: Dietary Supplement: Treatment vs control bread |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Measurements were assessed at baseline (T0) and eight weeks (T1)
Secondary outcomes (1)
Changes in the abundance of bacterial markers
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
Measured: Measurements were assessed at baseline (T0) and eight weeks (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start16 Dec 2019
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative Colitis in RemissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Aldeguer, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Investigators
- Xavier Aldeguer, Principal investigator, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656391
- Sponsor's protocol ID
- RTC-2017-CU
- Status last verified
- Dec 2022
- First submitted
- 1 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38363772
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bread Diet on Intestinal Dysbiosis and Irritable Bowel Syndrome Symptoms in Quiescent Ulcerative Colitis: A Pilot Study
- ClinicalTrials.gov ID
- NCT05656391
- Acronym / sponsor ID
- RTC-2017-CU
- Conditions
- Ulcerative Colitis in Remission
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment bread | Active comparator | Dietary Supplement: Treatment vs control breadDietary treatment consisted of daily consumption of 200 grams of bread produced following traditional breadmaking techniques |
| Control bread | Placebo comparator | Dietary Supplement: Treatment vs control breadDietary treatment consisted of daily consumption of 200 grams of bread produced following modern breadmaking techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment vs control breadConsumption of 200 grams per day of either treatment or control bread for eight weeks | Dietary supplement | Control bread, Treatment bread |
Primary outcome
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.
1 secondary outcome
Changes in the abundance of bacterial markers
Time frame: Measurements were assessed at baseline (T0) and eight weeks (T1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 38363772Lluansi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Aldeguer principal investigator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta (IdiBGi)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Ulcerative Colitis in Remission, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in IBS-like symptomatology (time frame: Measurements were assessed at baseline (T0) and eight weeks (T1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.