Probiotics in Short Bowel Syndrome

NCT03980327 | Completed

• 1 other identifier: H17-01054
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

Short bowel syndrome (SBS) occurs when there is insufficient intestinal mass to support normal growth and development. Approximately 30 out of every 100,000 babies are affected by SBS in North America, and these infants remain dependent on intravenous, parenteral nutrition (PN) for prolonged periods of time. Children with SBS frequently fail to achieve sufficient linear growth and weight gain despite receiving calories in excess of that required by age-matched healthy children. Poor intestinal absorption, motility and increased inflammation all contribute to poor growth in these patients. In addition, children with SBS are known to have significant disturbances to their normal commensal gut bacteria. They may experience a depletion of specific groups of beneficial gut bacteria, and their metabolic by-products, specifically short-chain fatty acids (SCFAs), which can lead to intestinal inflammation, malabsorption, and a less efficient use of consumed calories. In the proposed study, I hypothesize that children with SBS who are given supplements of targeted probiotics will have an increase in beneficial anti-inflammatory bacteria in their gut that more closely resembles the microbiota profile of healthy children. In addition, the children receiving probiotic supplementation will have increased concentrations of fecal SCFAs and improved growth compared to children with SBS who are not receiving supplementation. The central hypothesis will be tested by 1) prospectively characterizing the intestinal bacterial populations (by using next-gen sequencing methods), and measuring SCFA concentrations in the stool of children with SBS receiving probiotic treatment compared to those receiving no supplementation and 2) determining differences in the growth trajectory of the children in both groups by measuring sequential anthropometrics. Enrolled patients will be randomized to either continue with standard of care, or to receive a daily probiotic for 3 months. A total of 3 stool samples will be collected from each patient (at the beginning, midpoint and end of the study) and fecal 16S rDNA microbial sequencing and SCFA concentrations will be compared between groups, as will the groups growth trajectory. The long-term objective of the study is to determine how to effectively change the gut microbiota in children with SBS to restore a healthy balance and maximize growth and development. Although children with SBS have known disturbances to their intestinal microbiota, it is unclear whether providing an oral probiotic is an effective approach to correct these disturbances.

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• lactobacillus level

  relative abundance of Lactobacillus in the stool

  3 months

Secondary Outcomes (1)

• growth

  3 months

Study Arms (2)

probiotic

EXPERIMENTAL

Lactobacillus rhamnosus (5 billion colony forming units per day) and Lactobacillus johnsonii (200 million colony forming units per day) given orally or through a gastrostomy tube daily for 3 months

Dietary Supplement: probiotic

control

PLACEBO COMPARATOR

1 mL of pure medium chain triglyceride oil given orally or through a gastrostomy tube daily for 3 months

Dietary Supplement: medium chain triglyceride oil

Interventions

probiotic DIETARY_SUPPLEMENT

Lactobacillus probiotic

Also known as: Lactobacillus

probiotic

medium chain triglyceride oil DIETARY_SUPPLEMENT

Also known as: placebo

control

Eligibility Criteria

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

You may qualify if:

• have a diagnosis of short bowel syndrome (\<25% of their expected small bowel length based on age or \> 6 weeks of parenteral nutrition after small bowel resection
• cared for by the Intestinal Rehabilitation Team at Children's Health
• are receiving at least a portion of calories from enteral nutrition

You may not qualify if:

• have used probiotics within 2 weeks of enrollment
• are not able to come to regularly scheduled appointments during the study period
• are unwilling to collect stool samples

Sponsors & Collaborators

• British Columbia Children's Hospital: lead

MeSH Terms

Conditions

Short Bowel Syndrome

Interventions

Probiotics; Lacteol

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Surgeon

Model Details: randomized trial

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 10, 2019
• Study Start: January 4, 2017
• Primary Completion: October 27, 2018
• Study Completion: December 31, 2018
• Last Updated: June 11, 2019

Record last verified: 2019-06