Freeze-dried vs Fresh Fecal Microbiota Transplantation in Patients With Slow Transit Constipation

NCT02676388 | Unknown Phase 2 DMC

• 1 other identifier: Freeze-dried FMT-STC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the effect of freeze-dried, capsulized FMT and fresh FMT in adults with slow transit constipation.

Conditions

Slow Transit Constipation

Keywords

Slow Transit Constipation; Freeze-dried, Capsulized FMT; Fresh FMT

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)

Freeze-dried, Capsulized FMT

EXPERIMENTAL

Patients included will receive bowel lavage and subsequent Freeze-dried, Capsulized FMT, and then will be followed up for 3 months.

Procedure: Freeze-dried, Capsulized FMT

Fresh FMT

EXPERIMENTAL

Patients included will receive bowel lavage and subsequent Fresh FMT, and then will be followed up for 3 months.

Procedure: Fresh FMT

Interventions

Freeze-dried, Capsulized FMT PROCEDURE

Freeze-dried, Capsulized FMT

Fresh FMT PROCEDURE

Fresh 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

Freeze Drying

Intervention Hierarchy (Ancestors)

Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

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: February 3, 2016
• First Posted: February 8, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 15, 2016

Record last verified: 2016-03

Locations

CN (1)