Colitis, UlcerativeNCT03444311
Combined Nutritional Therapies for the Treatment of Ulcerative Colitis
A study testing A: 1 dosis and B: 2 dosis in people with Colitis, Ulcerative, run by AB Biotics, SA at 1 site in Spain.
Trial summary
Ulcerative colitis (UC) is an entity of complex etiology where environmental, genetic and intestinal microflora-related factors trigger and perpetuate a chronic inflammation of the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colitis, Ulcerative
- What is being tested?
- A: 1 dosis and B: 2 dosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 8 Mar 2018to 2 Jul 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (from 18 to 65 years old) diagnosed with ulcerative colitis (not distal), of at least 1 year of evolution of the disease.
- Patient in clinical remission two months prior to inclusion (Simple Colitis Clinical Activity Index (SCCAI) <4) and fecal calprotectin <150 μg / g.
- At least one outbreak in the last year that required systemic corticosteroids or escalating treatment (initiation of thiopurines, optimization of thiopurines, initiation of anti-TNF-alpha, intensification of anti-TNF-alpha, initiation of vedolizumab). At the time of entry into the study, the patient must carry with stable medication at least 2 months in the case of anti-TNF-alpha and mesalazine and 5 months in the case of thiopurine, and without treatment with corticosteroids
Who cannot join
- Patients with ulcerative proctitis only
- Patients who have received antibiotics the month prior to inclusion until completion
- Usual consumption of probiotics excluding fermented milk (yogurt, kefir ...).
- Supplementation with dietary fiber (without taking into account the one administered in the study).
- The smoking habit is allowed, although the beginning or abandonment of it from two months before the end of the study will have to be documented.
- Patients undergoing hypocaloric diets
Show all 12Show fewer
- Patients with stenosis or intestinal surgery
- Patients with primary sclerosing cholangitis
- Patients under treatment with ursodeoxycholic acid
- Patients under treatment with ion exchange resins
- Patients under treatment with acenocoumarol (Sintrom)
- The taking of proton pump inhibitors (PPIs) is allowed but their consumption must be controlled, not allowing them to start or suspend their intake during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota.
Ulcerative colitis (UC) is an entity of complex etiology where environmental, genetic and intestinal microflora-related factors trigger and perpetuate a chronic inflammation of the gastrointestinal tract. It is suspected that an alteration in primary intestinal microbial colonization (dysbiosis) could trigger, or at least contribute to, said oversized immune response. The hypothesis is that the administration of a series of fibers, could improve the bacterial diversity and repair the dysbiosis that has been seen in patients affected by ulcerative colitis, improving the clinical evolution of it. The primary objective of the present study is to know the impact on the microbiota of patients with UC in remission derived from the administration of dietary fibers. The RETOS study is a pilot project in which a population of patients with UC is tested for the effect on the composition of the microbiota that would have the administration of various combinations of fibers, in addition to the tolerability and acceptance by the patient. The clinical applicability derived from this intervention would be to improve the diversity of intestinal flora of patients with ulcerative colitis.
Read the detailed description
The Phase 1 study is a pilot project in which a population of patients with UC is tested for the effect on the composition of the microbiota that would have the administration of various combinations of fibers, in addition to the tolerability and acceptance by the patient. The study will include two groups of 20 patients each. One of the groups will receive 6 grams of fiber a day in a single shot with the main meal (group 1) and the other group will receive 12 grams of fiber a day divided into two meals with the main meals (group 2). Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups.
Description of the administration pattern Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B
A second sequential cycle similar to the first one (4 weeks with the same administration pattern) will be repeated in order to confirm the reproducibility of the findings.
The two formulas contain fibers known and commonly used in human nutrition, which were previously tested in in vitro models with human faeces and their ability to promote the growth of butyrate-producing bacterial species that are deficient in patients with colitis was proven ulcerative (Faecalibacterium prausnitzii and Roseburia hominis). The fibers are presented in aluminum envelopes to dissolve in a glass of water, juice, infusion or cold cream (max 37 ° C).
In addition, formulas A and B for group 1 (a single intake per day) include the mixture of probiotics i3.1 in quantity per envelope of 3e + 9 colony-forming units, which contains: Pediococcus acidilactici CECT 7483, Lactobacillus plantarum CECT 7484 and Lactobacillus plantarum CECT 7485 in a 1: 1: 1 ratio. Formulas A and B for group 2 (two intakes per day) include the probiotic i3.1 in quantity per envelope of 1.5e + 09 colony-forming units.
In the two groups, the first week the patients will receive half of the dose with the aim of facilitating the adaptation in those people who usually do not consume fiber. The usual diet, tolerability and patient satisfaction will be controlled through biweekly predefined questionnaires.
- Conditions
- Colitis, Ulcerative
- Being tested
- A: 1 dosis, B: 2 dosis
- Keywords
- microbiota, ulcerative colitis, fiber, probiotic
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A: 1 dosisDietary supplement
1 dosis (3E+09 cfu/d + 6 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups.
Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B
Composition of an envelope of formula A:
Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6
Composition of an envelope of formula B:
Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6
B: 2 dosisDietary supplement
1 dosis (3E+09 cfu/d + 12 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups.
Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B
Composition of an envelope of formula A:
Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6
Composition of an envelope of formula B:
Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6
| Study group | Role | What they receive |
|---|---|---|
| A: 1 dosis | Active comparator | 1 dosis (3E+09 cfu/day + 6 g of fiber/day) Receives: Dietary Supplement: A: 1 dosis |
| B: 2 dosis | Active comparator | 2 dosis (3E+09 cfu/day + 12 g of fiber/day) Receives: Dietary Supplement: B: 2 dosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To know the impact on the microbiota diversity by 16S rRNA analysis of patients with UC in remission derived from the administration of a new product based on dietary fibers
The phyla and genera relative abundance analysed by 16S rRNA before and after treatment with the two levels of fiber
Measured: 12 weeks
Secondary outcomes (2)
To study the tolerability of the product through questionnaires
Change from baseline in tolerability scores using the DHRS scale (0 no pain-5 severe pain) every 15 days
Measured: 4 months
To study the satisfaction of the product through questionnaires
Change from baseline in satisfaction scores using a (0 do not like-10 like a lot)scale every 15 days
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start8 Mar 2018
- Primary completion2 Jul 2019
- Study completion2 Jul 2020
Why it stopped: Low tolerability of fibers included in the product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colitis, UlcerativeStudies 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
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ariana Salavert, PhD, Study director, AB-Biotics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444311
- Sponsor's protocol ID
- RETOS
- Status last verified
- Jul 2020
- First submitted
- 8 Feb 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota.
- ClinicalTrials.gov ID
- NCT03444311
- Acronym / sponsor ID
- RETOS
- Conditions
- Colitis, Ulcerative
- Keywords
- microbiota, ulcerative colitis, fiber, probiotic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low tolerability of fibers included in the product
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 2 Jul 2020 (actual)
- First posted
- 23 Feb 2018 (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.
Ulcerative colitis (UC) is an entity of complex etiology where environmental, genetic and intestinal microflora-related factors trigger and perpetuate a chronic inflammation of the gastrointestinal tract. It is suspected that an alteration in primary intestinal microbial colonization (dysbiosis) could trigger, or at least contribute to, said oversized immune response. The hypothesis is that the administration of a series of fibers, could improve the bacterial diversity and repair the dysbiosis that has been seen in patients affected by ulcerative colitis, improving the clinical evolution of it. The primary objective of the present study is to know the impact on the microbiota of patients with UC in remission derived from the administration of dietary fibers. The RETOS study is a pilot project in which a population of patients with UC is tested for the effect on the composition of the microbiota that would have the administration of various combinations of fibers, in addition to the tolerability and acceptance by the patient. The clinical applicability derived from this intervention would be to improve the diversity of intestinal flora of patients with ulcerative colitis.
Detailed description
The Phase 1 study is a pilot project in which a population of patients with UC is tested for the effect on the composition of the microbiota that would have the administration of various combinations of fibers, in addition to the tolerability and acceptance by the patient. The study will include two groups of 20 patients each. One of the groups will receive 6 grams of fiber a day in a single shot with the main meal (group 1) and the other group will receive 12 grams of fiber a day divided into two meals with the main meals (group 2). Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups.
Description of the administration pattern Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B
A second sequential cycle similar to the first one (4 weeks with the same administration pattern) will be repeated in order to confirm the reproducibility of the findings.
The two formulas contain fibers known and commonly used in human nutrition, which were previously tested in in vitro models with human faeces and their ability to promote the growth of butyrate-producing bacterial species that are deficient in patients with colitis was proven ulcerative (Faecalibacterium prausnitzii and Roseburia hominis). The fibers are presented in aluminum envelopes to dissolve in a glass of water, juice, infusion or cold cream (max 37 ° C).
In addition, formulas A and B for group 1 (a single intake per day) include the mixture of probiotics i3.1 in quantity per envelope of 3e + 9 colony-forming units, which contains: Pediococcus acidilactici CECT 7483, Lactobacillus plantarum CECT 7484 and Lactobacillus plantarum CECT 7485 in a 1: 1: 1 ratio. Formulas A and B for group 2 (two intakes per day) include the probiotic i3.1 in quantity per envelope of 1.5e + 09 colony-forming units.
In the two groups, the first week the patients will receive half of the dose with the aim of facilitating the adaptation in those people who usually do not consume fiber. The usual diet, tolerability and patient satisfaction will be controlled through biweekly predefined questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: 1 dosis | Active comparator | Dietary Supplement: A: 1 dosis1 dosis (3E+09 cfu/day + 6 g of fiber/day) |
| B: 2 dosis | Active comparator | Dietary Supplement: B: 2 dosis2 dosis (3E+09 cfu/day + 12 g of fiber/day) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (from 18 to 65 years old) diagnosed with ulcerative colitis (not distal), of at least 1 year of evolution of the disease.
- Patient in clinical remission two months prior to inclusion (Simple Colitis Clinical Activity Index (SCCAI) <4) and fecal calprotectin <150 μg / g.
- At least one outbreak in the last year that required systemic corticosteroids or escalating treatment (initiation of thiopurines, optimization of thiopurines, initiation of anti-TNF-alpha, intensification of anti-TNF-alpha, initiation of vedolizumab). At the time of entry into the study, the patient must carry with stable medication at least 2 months in the case of anti-TNF-alpha and mesalazine and 5 months in the case of thiopurine, and without treatment with corticosteroids
Key exclusion criteria (12 listed)
- Patients with ulcerative proctitis only
- Patients who have received antibiotics the month prior to inclusion until completion
- Usual consumption of probiotics excluding fermented milk (yogurt, kefir ...).
- Supplementation with dietary fiber (without taking into account the one administered in the study).
- The smoking habit is allowed, although the beginning or abandonment of it from two months before the end of the study will have to be documented.
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 |
|---|---|---|
| A: 1 dosis1 dosis (3E+09 cfu/d + 6 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups. Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B Composition of an envelope of formula A: Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6 Composition of an envelope of formula B: Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6 | Dietary supplement | A: 1 dosis |
| B: 2 dosis1 dosis (3E+09 cfu/d + 12 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups. Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B Composition of an envelope of formula A: Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6 Composition of an envelope of formula B: Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6 | Dietary supplement | B: 2 dosis |
Primary outcome
To know the impact on the microbiota diversity by 16S rRNA analysis of patients with UC in remission derived from the administration of a new product based on dietary fibers
Time frame: 12 weeks
The phyla and genera relative abundance analysed by 16S rRNA before and after treatment with the two levels of fiber
2 secondary outcomes
To study the tolerability of the product through questionnaires
Time frame: 4 months
To study the satisfaction of the product through questionnaires
Time frame: 4 months
Results and safety
The study was stopped early (reason given: Low tolerability of fibers included in the product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
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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.
Ariana Salavert, PhD study director
AB-Biotics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A: 1 dosis and B: 2 dosis in people with Colitis, Ulcerative, run by AB Biotics, SA 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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 8 Jul 2020. 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. 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 was stopped early (reason given: Low tolerability of fibers included in the product). Results are not available in the source record.
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?
To know the impact on the microbiota diversity by 16S rRNA analysis of patients with UC in remission derived from the administration of a new product based on dietary fibers (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2020.