Effect of Fecal Microbiota Transplantation in Slow Transit Constipation

NCT02301221 | Unknown Phase 2 DMC

• 1 other identifier: RIGS-FMT-STC-2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.

Conditions

Slow Transit Constipation

Keywords

Fecal Microbiota Transplantation; Slow Transit Constipation; Colonic motility

Outcome Measures

Primary Outcomes (1)

• Proportion of patients having on average three or more SCBMs/week

  Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at baseline and over the week interval 3-4, 9-12 and 21-24.

  24 weeks

Secondary Outcomes (6)

• Bowel habit assessments

  24 weeks

• Constipation-related symptoms assessments

  24 weeks

• Quality-of-Life assessments

  24 weeks

• Colonic transit time measurements

  24 weeks

• Usage of laxatives or enemas as rescue medication

  24 weeks

Study Arms (1)

Fecal microbiota transplantation (FMT)

EXPERIMENTAL

Patients included will receive standard FMT, and then will be followed up for 24 weeks.

Procedure: Fecal microbiota transplantation (FMT); Drug: Vancomycin and bowel lavage

Interventions

Fecal microbiota transplantation (FMT) PROCEDURE

Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Also known as: Fecal bacteriotherapy

Fecal microbiota transplantation (FMT)

Vancomycin and bowel lavage DRUG

An initial vancomycin regimen (500 mg orally two times per day for 3 days), followed by bowel lavage before the infusion of a solution of donor fecal microbiota.

Fecal microbiota transplantation (FMT)

Eligibility Criteria

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

You may qualify if:

• Chronic constipation according to Rome III criteria, defined as two or fewer spontaneous, complete bowel movements (SCBMs) per week for a minimum of 6 months;
• Age ≥ 18 years;
• BMI: 18.5-25 kg/m2;
• Slow colonic transit confirmed by colonic transit test (colonic transit time (CTT) \> 48 hours);
• Normal anorectal manometry with no evidence of dyssynergia and confirmed ability to expel rectal balloon;
• No radiographic evidence of functional (i.e. pelvic floor dyssynergia) or anatomical (i.e. significant rectocele and intussusception) impediment to the expulsion of the radio-opaque contrast;
• Disease duration \> 1 year;
• Traditional treatment with dietary modification, laxatives (including osmotic and stimulant laxatives), and biofeedback tried over the past 6 months without success;

You may not qualify if:

• Bowel constipation due to innate factor (i.e. megacolon) or secondary interventions (i.e. drugs, endocrine, metabolic, neurologic or psychologic disorders);
• History or evidence of gastrointestinal diseases (i.e. obstruction, cancer, inflammatory bowel diseases) ;
• Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation and cesarean section;
• Previous proctological or perianal surgery;
• A constipation condition meeting the Rome III criteria for IBS or functional abdominal pain syndrome;
• Pregnant or breast-feeding women;
• Infection with enteric pathogen;
• Usage of probiotics, prebiotics and/or synbiotics within the last month;
• Usage of antibiotics and/or PPIs within the last 3 months;
• Smoking or alcohol addiction within the last 3 months;
• Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;
• Disease or therapy with drugs (i.e. antidepressants, opioid narcotic analgesics, anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Interventions

Fecal Microbiota Transplantation; Vancomycin

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ning Li, MD

  Department of Generay Surgery, Jinling hosptal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 25, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

CN (1)