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

Information source: Jinling Hospital, China
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Slow Transit Constipation

Intervention: Pectin (Drug); Placebo (Other); Fecal microbiota transplantation (FMT) (Procedure)

Phase: Phase 2

Status: Recruiting

Sponsored by: Jinling Hospital, China

Official(s) and/or principal investigator(s):
Ning Li, MD, Study Director, Affiliation: Department of Generay Surgery, Jinling hosptal

Overall contact:
Jianfeng Gong, MD, Phone: +86-25-80860036, Email: gongjianfeng@aliyun.com

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.

Clinical Details

Official title: A Randomized, Controlled Study of Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Change of fecal bacteriology

Secondary outcome:

Clinical response evaluation

Change of fecal SCFAs

Change of colonic transit time and pressure

Usage of laxatives or enemas when necessary

Adverse events

Detailed description:

Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide

general population. Recent evidence in the literature and collected in our laboratory confirm that constipation can be a consequence of intestinal dysbiosis, which may affect the motility and metabolic environment of colon. Fecal Microbiota Transplantation (FMT) is temporarily effective for patients with slow transit constipation. However, the transplanted microflora cannot maintain for a long time. Along with the gut microbiota returning to the original state, the symptoms relapse. Pectin is a kind of soluble dietary fiber, producing short chain fatty acids (SCFAs) after a series of fermentation by gut flora to supply the energy for epithelial cells, regulate intestinal PH, promote intestinal motility and join effort in immune regulation with intestinal lymphoid tissue. Therefore, we conceive that pectin could promote the colonization of probiotics and reduce adhesion of pathogens.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Chronic constipation according to Rome III criteria

- Age ≥ 18 years

- BMI: 18. 5 - 25 kg/m2

- Slow transit constipation confirmed by a thorough examination (coexistence of mild

obstructed defecation syndrome is permitted)

- Traditional treatment with diet, laxatives (including osmotic, and stimulant

laxatives), enemas, and biofeedback tried over the past 6 months without success Exclusion Criteria:

- Bowel constipation due to innate factor (e. g. megacolon) or secondary interventions

(e. g. drugs, endocrine, metabolic, neurologic or psychologic disorders);

- History or evidence of gastrointestinal diseases (e. g. cancer, inflammatory bowel

diseases) ;

- Previous abdominal surgery, except cholecystectomy, appendicectomy, tubal ligation

and cesarean section;

- Previous proctological or perianal surgery;

- Rectal prolapse and/or grade 3-4 internal hemorrhoids according to AGA

classification;

- 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, antibiotics or PPIs within the last month;

- Smoking or alcohol addiction within the last 3 months;

- Uncontrolled hepatic, renal, cardiovascular, respiratory or psychiatric disease;

- Disease or therapy with drugs (e. g. antidepressants, opioid narcotic analgesics,

anticholinergics, calcium antagonists, nitrates, antimuscarinics) that, in the opinion of the investigator, could affect intestinal transit and microbiota.

Locations and Contacts

Jianfeng Gong, MD, Phone: +86-25-80860036, Email: gongjianfeng@aliyun.com

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University, Nanjing, Jiangsu 210002, China; Recruiting
Ning Li, MD, Phone: +86-25-80860089, Email: liningrigs@vip.sina.com
Jianfeng Gong, MD, Principal Investigator
Chao Ding, MD candidate, Sub-Investigator
Hongliang Tian, PhD candidate, Sub-Investigator
Xiaolong Ge, MD candidate, Sub-Investigator
Additional Information

Starting date: December 2014
Last updated: August 15, 2015

Page last updated: August 23, 2015

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