Effect of a Synbiotic on Symptoms of Patients With STC

NCT02844426 | Completed Phase 2 DMC

• 1 other identifier: BIFICOPEC-2015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of synbiotic (BIFICOPEC) containing Enterococci, Bifidobacteria, Lactobacilli triple viable bacteria and pectin in patients with slow transit constipation.

Conditions

Slow Transit Constipation

Keywords

synbiotic; soluble dietary fiber; slow transit constipation; microbiota

Outcome Measures

Primary Outcomes (2)

• Clinical remission rate

  Patients having an average of three or more spontaneous complete bowel movements (SCBMs) per week were defined as remission.

  3 months

• Clinical improvement rate

  Patients with an average increase of one or more spontaneous complete bowel movements (SCBMs) per week were defined as improvement.

  3 months

Secondary Outcomes (9)

• Number of bowel movements per week

  3 months

• Stool consistency according to the Bristol Stool Form Scale (BSFS)

  3 months

• Colonic transit time (CTT)

  3 months

• Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire

  3 months

• The Gastrointestinal Quality-of-Life Index (GIQLI)

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

patients allowed to take maltodextrin by the experienced doctor.

Drug: maltodextrin

synbiotic

EXPERIMENTAL

patients are allowed to take synbiotic (BIFICOPEC) contained 0.63g bifid triple viable capsule (BIFICO) and 8g soluble dietary fiber (Pectin) .

Drug: bifid triple viable capsule and pectin

Interventions

bifid triple viable capsule and pectin DRUG

synbiotic

maltodextrin DRUG

Placebo

Eligibility Criteria

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

You may qualify if:

• age ≥ 18 years;
• BMI: 18.5-25kg/m2;
• chronic constipation was diagnosed according to RomeⅢ criteria;
• colonic transit time (CTT) \>48 hours;
• mild-to-moderate constipation with wexner constipation scale between 16 and 25.

You may not qualify if:

• megacolon, intestinal obstruction, inflammatory bowel disease, and cancer;
• secondary constipation (i.e. drugs, endocrine disorders, neurological disorders, metabolic disorders, psychological disorders or abdominal surgery);
• severe anterior rectocele or full thickness rectorectal intussusception according to defecography;
• pregnant or lactating women;
• infection with enteric pathogen;
• usage of antibiotics or proton pump inhibitors (PPIs);
• hepatic, renal, cardiovascular, respiratory or psychiatric disease;
• other diseases or factors evaluated by the investigator which could influence intestinal transit or intestinal 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

Pectins; maltodextrin

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ning Li

  department of generay surgery, jinling hospital

  STUDY DIRECTOR

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: Professor

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 26, 2016
• Study Start: September 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 30, 2016

Record last verified: 2016-09

Locations

CN (1)