Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

NCT02526849 | Unknown Phase 2 DMC

• 1 other identifier: RCT-FMT-STC-2015
• Study Type: interventional
• Target: 100
• 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; Randomized Controlled Trial

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 week 4 and 12.

  3 months

Secondary Outcomes (7)

• Mean number of bowel movements per week

  3 months

• Characteristics of bowel movements

  3 months

• Constipation-related symptoms assessments

  3 months

• Quality-of-Life assessments

  3 months

• Colonic transit time measurements

  3 months

Study Arms (2)

Fecal microbiota transplantation (FMT)

EXPERIMENTAL

On day 1-6, patients received 100ml fresh FMT by nasointestinal tube, once per day. The nasointestinal tube was placed in the patient's proximal jejunum through endoscopy. Then, donor fecal microbiota was infused within 5 minutes through nasointestinal tube.

Drug: Fecal microbiota transplantation (FMT); Behavioral: Conventional treatment

Conventional treatment

EXPERIMENTAL

Conventional treatment was taken by both of two groups. If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax®, Ipsen, Paris, France). If ineffective, an enema could be used.

Drug: Fecal microbiota transplantation (FMT); Behavioral: Conventional treatment

Interventions

Fecal microbiota transplantation (FMT) DRUG

Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Also known as: Fecal bacteriotherapy

Conventional treatment; Fecal microbiota transplantation (FMT)

Conventional treatment BEHAVIORAL

Conventional treatment was taken by both of two groups. If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax®, Ipsen, Paris, France). If ineffective, an enema could be used.

Conventional treatment; 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

RECRUITING

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Central Study Contacts

Jianfeng Gong, MD

CONTACT

+86-25-80860036; jinlingh_gongjf@126.com

Ning Li, MD

CONTACT

+86-25-80860089; jinlingh_lining@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: August 14, 2015
• First Posted: August 18, 2015
• Study Start: November 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

CN (1)