Probiotics and Recovery From Gastrointestinal Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-10-31

Brief Summary

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This prospective randomized trial is designed to test a pragmatic simple intervention in a community hospital. The trial will test the hypothesis whether patient recovery after a major elective abdominal operation can be improved and/or accelerated with postoperative use of probiotics.

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Detailed Description

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Conditions

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Surgical Recovery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo Comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

One capsule po BID for 28 days

probiotic

Group Type EXPERIMENTAL

SuperBio probiotic

Intervention Type DRUG

One capsule po BID for 28 days

Interventions

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SuperBio probiotic

One capsule po BID for 28 days

Intervention Type DRUG

Placebo

One capsule po BID for 28 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults aged ≥18 years undergoing elective major abdominal operation
* Functional GI tract expected after operation

Exclusion Criteria

* Current episode of acute necrotizing pancreatitis as defined by surgeon
* Palliative decompressive GI tube
* Life expectancy ≤ 6 months
* Systemic immune-mediated disease active requiring systemic therapy:
* Prednisone ≥20 mg QD
* IV immunoglobulins
* Anti-rejection medication
* Presence of functional transplanted organ
* Systemic collagen-related disease treated with immunomodulating agents, including rheumatoid arthritis, SLE, scleroderma, etc.
* Topical chemotherapy or corticosteroids, and chemotherapy applied during operation are allowed
* Patient taking probiotics, synbiotics, or cobiotics as part of their lifestyle
* Need for full systemic anticoagulation postoperatively.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No