Inflammatory Bowel DiseasesNCT05456763
Butyrate in Pediatric Inflammatory Bowel Disease
A study testing sodium butyrate in people with Inflammatory Bowel Diseases, run by Centre of Postgraduate Medical Education.
Trial summary
The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- sodium butyrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jun 2022
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 6 to 18 years of age;
- newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
- informed consent of the child's parents or guardians to participate in the study.
Who cannot join
- age <6 years;
- taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
- lack of consent of parents or guardians to participate in the study.
About this study
Official title: Sodium Butyrate Effectiveness in Children and Adolescents With Newly Diagnosed Inflammatory Bowel Diseases - Randomized Placebo-controlled Multicentre Trial
The first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.
Read the detailed description
Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD.
This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- sodium butyrate, placebo
- Keywords
- Crohn's disease, ulcerative colitis, sodium butyrate
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium butyrateDietary supplement
add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | 150 mg sodium butyrate twice a day for 12 weeks Receives: Dietary Supplement: sodium butyrate |
| group B | Placebo comparator | placebo capsules twice a day for 12 weeks Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in remission rate (PCDAI for Crohn's disease)
The Pediatric Crohn's Disease Activity Index (PCDAI) measured in points of activity was used to assess CD activity.
Severity of the disease:
<10 points = remission 10-27.5 points = mild Crohn's Disease 30-37.5 points = moderate Crohn's Disease
≥40 points = severe Crohn's Disease
In this scale addominal pain (mild or moderate/severe), number of stools per day, general well being (good, below par, very poor), antropometric measures, palpable mass in the abdomen and perianal fistulas are assessed. The scale is validated and used in daily clinical practice.
Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
Measured: 12 weeks
difference in remission rate (PUCAI ulcerative colitis)
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measured in points of activity was used to assess UC activity.
Severity of the disease:
<10 points = remission 10-34 points = mild ulcerative colitis 35-64 points = moderate ulcerative colitis
≥65 points = severe ulcerative colitis
In this scale addominal pain (mild or moderate/severe), number of stools per day, blood in the stool, stool consistency, nocturnal stools and activity level (no limitation, occasional or restricted), are assessed. The scale is validated and used in daily clinical practice.
Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
Measured: 12 weeks
Secondary outcomes (3)
difference in disease activity for CD and UC patients
assessed separately, calcultated in points (described above)
Measured: 12 weeks
difference in calprotectin concentration
measured in µg/g assessed in different soubgroups (lower result is better, remission = less than 50.
Measured: 12 weeks
side effects
assessed for both groups (descriptive)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJun 2013
- Primary completionFeb 2016
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre of Postgraduate Medical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05456763
- Sponsor's protocol ID
- nr 41/2013
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2022
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Butyrate Effectiveness in Children and Adolescents With Newly Diagnosed Inflammatory Bowel Diseases - Randomized Placebo-controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT05456763
- Acronym / sponsor ID
- nr 41/2013
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- Crohn's disease, ulcerative colitis, sodium butyrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre of Postgraduate Medical EducationUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 13 Jul 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 first prospective randomised placebo-controlled study in the IBD pediatric population was conducted to evaluate the effectiveness of oral sodium butyrate as add-on therapy in IBD.
Detailed description
Butyric acid's effectiveness has not yet been assessed in the pediatric inflammatory bowel disease (IBD) population. This study aimed to evaluate the effectiveness of oral sodium butyrate as an add-on to standard therapy in children and adolescents with newly diagnosed IBD.
This was a prospective, randomized, placebo-controlled multicentre study. Patients aged 6-18 years with colonic Crohn's disease or ulcerative colitis, who received standard therapy depending on the disease's severity, were randomized to receive 150 mg sodium butyrate twice a day (group A) or placebo (group B). The primary outcome was the difference in disease activity and fecal calprotectin concentration between the two study groups measured at 12 weeks of the study.
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 |
|---|---|---|
| group A | Experimental | Dietary Supplement: sodium butyrate150 mg sodium butyrate twice a day for 12 weeks |
| group B | Placebo comparator | Other: placeboplacebo capsules twice a day for 12 weeks |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 6 to 18 years of age;
- newly diagnosed, based on the modified Porto criteria, IBD with colon involvement;
- informed consent of the child's parents or guardians to participate in the study.
Key exclusion criteria (3 listed)
- age <6 years;
- taking probiotics or dietary supplements in the last 2 weeks prior to study enrollment;
- lack of consent of parents or guardians to participate in the study.
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 |
|---|---|---|
| sodium butyrateadd-on therapy irrespective of standard treatment depending on severity (according to the guidelines) | Dietary supplement | group A |
| placeboplacebo | Other | group B |
Primary outcome
difference in remission rate (PCDAI for Crohn's disease)
Time frame: 12 weeks
The Pediatric Crohn's Disease Activity Index (PCDAI) measured in points of activity was used to assess CD activity. Severity of the disease: <10 points = remission 10-27.5 points = mild Crohn's Disease 30-37.5 points = moderate Crohn's Disease ≥40 points = severe Crohn's Disease In this scale addominal pain (mild or moderate/severe), number of stools per day, general well being (good, below par, very poor), antropometric measures, palpable mass in the abdomen and perianal fistulas are assessed. The scale is validated and used in daily clinical practice. Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
difference in remission rate (PUCAI ulcerative colitis)
Time frame: 12 weeks
The Pediatric Ulcerative Colitis Activity Index (PUCAI) measured in points of activity was used to assess UC activity. Severity of the disease: <10 points = remission 10-34 points = mild ulcerative colitis 35-64 points = moderate ulcerative colitis ≥65 points = severe ulcerative colitis In this scale addominal pain (mild or moderate/severe), number of stools per day, blood in the stool, stool consistency, nocturnal stools and activity level (no limitation, occasional or restricted), are assessed. The scale is validated and used in daily clinical practice. Remission was defined as less than 10 points for both PCDAI and PUCAI scores.
3 secondary outcomes
difference in disease activity for CD and UC patients
Time frame: 12 weeks
difference in calprotectin concentration
Time frame: 12 weeks
side effects
Time frame: 12 weeks
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 13 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sodium butyrate in people with Inflammatory Bowel Diseases, run by Centre of Postgraduate Medical Education.
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 3 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 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
difference in remission rate (PCDAI for Crohn's disease) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 13 Jul 2022.