Synbiotics and Post-op Crohn's Disease

NCT04804046 | Terminated DMC

• 1 other identifier: Pro00092967
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

Brief Summary

Crohn's disease (CD) is a lifelong incurable condition that causes inflammation of the intestinal tract of humans. The exact cause of CD is unknown, but genetics, diet, and the gut microbiome are all thought to play a major role. Many patients with CD will require surgery to remove affected portions of the gut, with ileocecal resections being the most common procedure performed. Regrettably, there is up to an 85% chance that disease returns to the surgical site. Strong immune suppressive medications may help to prevent disease relapse. However, patients are then at risk of serious side effects. Currently, no ideal post-op care exists for CD patients. This study aims to assess whether a post-op synbiotic therapy (i.e. probiotics plus dietary fiber) prevents disease relapse in participants with CD. To test this, participants will consume probiotics (strains of bifidobacteria) before their surgery and then probiotics plus fiber supplements after surgery. Probiotics are live bacteria that have been shown to reduce inflammation of the gut. Fiber is given after surgery to help promote beneficial bacterial taxa and prevent less favorable bacterial taxa from triggering CD relapse. Patients will take the supplements for 6 months following surgery. They will be seen monthly to assess the effects of treatment on quality of life, symptoms of disease recurrence, inflammatory markers, and the gut microbiome. All patients will also undergo a colonoscopy at the end of the study to check for endoscopic reoccurrence.

Conditions

Crohn's Disease

Keywords

Crohn's Disease; Inflammation; Probiotics; Prebiotics; Dietary Fiber; Synbiotics; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• The percentage of participants who experience treatment emergent adverse and serious adverse events

  The primary objective of this study is to determine the safety and tolerability of a synbiotic treatment as assessed by the percentage of participants who experience treatment emergent adverse and serious adverse events.

  6-month period

Secondary Outcomes (12)

• Changes in quality of life (1)

  6-month period

• Changes in quality of life (2)

  6-month period

• Prevention of clinical recurrence

  6-month period

• Prevention of endoscopic recurrence

  6-month period

• Changes in systemic inflammation

  6-month period

Study Arms (2)

Synbiotic

EXPERIMENTAL

Bifidobacterium longum spp. longum R0175, Bifidobacterium animalis spp. Lafti B94, Bifidobacterium bifidum R0071 at 3x10\^9 CFU/d plus resistant starch type 2, arabinoxylan, and galactooligosaccharide at 24 g/d will serve as the treatment.

Dietary Supplement: Synbiotic

Digestible Maltodextrin

PLACEBO COMPARATOR

Digestible maltodextrin will serve as the placebo.

Other: Digestible Maltodextrin

Interventions

Synbiotic DIETARY_SUPPLEMENT

Eighteen participants with Crohn's disease that are undergoing an ileocecal resection will supplement their normal diet with three Bifidobacterium spp. (3x10\^9 CFU) plus three dietary fibers (24 g fiber) daily for six months.

Also known as: Resistant starch type 2; HiMaize 260; Ingredion, Arabinoxylan; Naxus; Bioactive, Galactooligosaccharide; Vivinal; FrieslandCampina

Synbiotic

Digestible Maltodextrin OTHER

Eighteen participants with Crohn's disease that are undergoing an ileocecal resection will supplement their normal diet with Maltodextrin daily for six months.

Also known as: Maltodextrin GLOBE Plus 15; Ingredion

Digestible Maltodextrin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Crohn's disease
• Undergoing ileocolonic resection
• Females of childbearing potential must agree to use a medically approved method of birth control (e.g. hormonal contraception, intrauterine devices, vasectomy/tubal ligation, barrier methods, double-barrier method) and must have negative pregnancy test results at screening and baseline.

You may not qualify if:

• Subjects which are reliant on partial or total parenteral nutrition
• Subjects with permanent or temporary diverting ileostomies
• Subjects with gluten intolerance/sensitivity
• Subjects with milk or soy allergy
• Subjects with diabetes, immune disorders, or bleeding disorders
• Subjects with any documented psychological disorders
• Pregnant women, women who are breast feeding, or women planning on becoming pregnant
• Subjects with perforation or ischemia of the gut
• Subjects unable to tolerate any oral intake following surgery
• Subjects with immune-compromised condition (e.g. AIDS, lymphoma)
• Subjects who are taking tetracycline
• Subjects with uncontrolled cardiovascular or respiratory disease or active malignancy
• Subjects who are enrolled in another clinical trial
• Subjects who are unable to give informed consent

Sponsors & Collaborators

• University of Alberta: lead
• W. Garfield Weston Foundation: collaborator

Study Sites (5)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, T5R 4H5, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

Location

University of Alberta Human Nutrition Research Unit

Edmonton, Alberta, T6G 2E1, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6L 5X8, Canada

Location

MeSH Terms

Conditions

Crohn Disease; Inflammation

Interventions

Synbiotics; arabinoxylan

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Karen L Madsen, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: July 15, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)