Butyrate in Pediatric Inflammatory Bowel Disease

NCT05456763 | Completed

• 1 other identifier: nr 41/2013
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Inflammatory Bowel Diseases

Keywords

Crohn's disease; ulcerative colitis; sodium butyrate

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Secondary Outcomes (3)

• difference in disease activity for CD and UC patients

  12 weeks

• difference in calprotectin concentration

  12 weeks

• side effects

  12 weeks

Study Arms (2)

group A

EXPERIMENTAL

150 mg sodium butyrate twice a day for 12 weeks

Dietary Supplement: sodium butyrate

group B

PLACEBO COMPARATOR

placebo capsules twice a day for 12 weeks

Other: placebo

Interventions

sodium butyrate DIETARY_SUPPLEMENT

add-on therapy irrespective of standard treatment depending on severity (according to the guidelines)

group A

placebo OTHER

placebo

group B

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre of Postgraduate Medical Education: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

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: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 13, 2022
• Study Start: June 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07