Rifaximin and Misoprostol Combination Therapy for Healing of Small Bowel Ulcers in Aspirin Users

NCT03962283 | Unknown Phase 2

• 1 other identifier: MISO RF
• Study Type: interventional
• Target: 78
• Locations: 2 countries
• Sites: 2

Brief Summary

Background: Investigators have previously shown that misoprostol can heal small bowel ulcers in aspirin users with small bowel bleeding. However, the rate of small-bowel mucosal healing was low with use of misoprostol alone. There is evidence to suggest that bacteria contribute to the development aspirin-induced ulcers and antibiotics may be useful in its treatment. Rifaximin, a non-absorbed oral antibiotic that target the gastrointestinal tract have been shown to be safe and effective in a few other gastrointestinal conditions. Small bowel capsule is the most sensitive and non-invasive way to investigate the small bowel. It plays an important role in obscure GIB investigations. Aims: The aim of this randomized study is to test the hypothesis that misoprostol combined with rifaximin is superior to misoprostol alone for healing of small bowel ulcers in aspirin users complicated by small bowel bleeding. Study design: 8-week double-blind randomized trial

Conditions

Small Bowel Disease; Rifaximin

Outcome Measures

Primary Outcomes (1)

• Healing of small bowel ulcers

  Capsule endoscopy will be performed to check if there is complete healing of small bowel ulcers, with or without red spots.

  8 weeks after randomization

Secondary Outcomes (2)

• Change in numbers of ulcer/erosions

  8 weeks after randomization

• Change in blood hemoglobin level

  8 weeks after randomization

Study Arms (2)

Rifaximin

ACTIVE COMPARATOR

ASA daily + misoprostol + Rifaximin (Rifaximin group)

Drug: Rifaximin

Rifaximin Placebo

PLACEBO COMPARATOR

ASA daily + misoprostol + Placebo Rifaximin (Placebo group)

Drug: Placebo oral tablet

Interventions

Rifaximin DRUG

Rifaximin 200mcg four times daily

Rifaximin

Placebo oral tablet DRUG

Placebo Rifaximin four times daily

Rifaximin Placebo

Eligibility Criteria

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

You may qualify if:

• Suspected small bowel overt bleeding - melena or hematochezia with or without a source of bleeding from gastroscopy and colonoscopy or suspected small bowel occult blood loss - defined as a significant decrease in hemoglobin (\> 2g/dL), without a source of bleeding from gastroscopy and colonoscopy, confirmed iron deficiency anemia, and absence of other identifiable causes for hemoglobin decrease (e.g. fluid overload, progressive renal failure, malnutrition, or other hematological disorders such as hemolysis or malignancies)
• Continuous use of aspirin for the duration of the trial
• Age ≥ 18
• Written informed consent obtained

You may not qualify if:

• Increased risk of capsule retention (e.g. gastric outlet obstruction, bypass surgery, Crohn's disease or suspected small bowel stricture)
• Abnormal findings on gastroscopy that may account for bleeding episode: clean-based ulcer \>2 cm or \>5 erosions, esophageal varices, grade C or D erosive esophagitis, vascular malformations
• Unable to swallow the capsule endoscopy
• Terminal illness
• Concomitant use of NSAIDs, sucralfate, rebamepide, antibiotics, corticosteroids (prednisolone \>7.5 mg daily or equivalent), and iron supplement
• Pregnancy (except LMP within 7 days) or women of child-bearing age without regular use of contraception
• Contraindications to colonoscopy or capsule endoscopy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Beijing Friendship Hospital: collaborator

Study Sites (2)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 000, China

RECRUITING

Prince of Wales Hospital

Hong Kong, 000, Hong Kong

RECRUITING

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Francis Chan, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica CHING, MPH

CONTACT

+852 3505 3524; jessicaching@cuhk.edu.hk

Pui Kuan Cheong, MPH

CONTACT

+852 3505 3476; jcheong@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 24, 2019
• Study Start: August 2, 2019
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2023
• Last Updated: July 1, 2020

Record last verified: 2020-06

Locations

HK (1); CN (1)