Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Slow Transit Constipation

NCT02291354 | Unknown Phase 2 DMC

• 1 other identifier: RIGS-Pectin-STC-2015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the synergism of Soluble Dietary Fiber with Fecal Microbiota Transplantation in Adult Patients with Slow Transit Constipation.

Conditions

Slow Transit Constipation

Keywords

Fecal Microbiota Transplantation; Soluble Dietary Fiber; Slow Transit Constipation

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.

  12 weeks

Secondary Outcomes (6)

• Bowel habit assessments

  12 weeks

• Constipation-related symptoms assessments

  12 weeks

• Quality-of-Life assessments

  12 weeks

• Colonic transit time measurements

  12 weeks

• Usage of laxatives or enemas as rescue medication

  12 weeks

Study Arms (2)

FMT + Placebo

PLACEBO COMPARATOR

Patients allocated to control group will receive standard FMT, followed by placebo for 12 weeks.

Other: Placebo; Procedure: Fecal microbiota transplantation (FMT)

FMT + Pectin

EXPERIMENTAL

Patients allocated to experiment group will receive standard FMT, followed by 24g pectin each day for 12 weeks.

Drug: Pectin; Procedure: Fecal microbiota transplantation (FMT)

Interventions

Pectin DRUG

Patients allocated to experiment group will receive 12 g pectin each day for 12 weeks.

Also known as: soluble dietary fiber

FMT + Pectin

Placebo OTHER

Patients allocated to experiment group will receive 12 g maltodextrin each day for 12 weeks.

FMT + Placebo

Fecal microbiota transplantation (FMT) PROCEDURE

Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Also known as: Fecal bacteriotherapy

FMT + Pectin; FMT + Placebo

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

Pectins; Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Biological Therapy; Therapeutics

Study Officials

• Ning Li, MD

  Department of Generay Surgery, Jinling hosptal

  STUDY DIRECTOR

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: November 11, 2014
• First Posted: November 14, 2014
• Study Start: March 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 4, 2016

Record last verified: 2015-11

Locations

CN (1)