Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

NCT ID: NCT02526849

Last Updated: 2016-11-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-06-30

Brief Summary

The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.

Detailed Description

Constipation is a chronic disease estimated to affect about 10% - 15% of the worldwide general population. Constipation frequency appears to augment with increasing age, particularly after 65 years old.

Recent evidence in the literature and collected in the investigators' laboratory confirm that constipation can be a consequence of intestinal dysbiosis, with an increase of potentially pathogenic microorganisms and a decrease of potentially beneficial microorganisms. These alterations may affect the motility and metabolic environment of colon, especially the production of short chain fatty acids (SCFAs).

A new and under-explored method to manipulate the gastrointestinal microbiota involves fecal microbiota transplantation (FMT). There has been growing interest in the use of fecal microbiota for the treatment of patients with chronic gastrointestinal infections (e.g. CDI) and other extraintestinal conditions (e.g. IBD). Similarly, the investigators suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.

Conditions

Slow Transit Constipation

Keywords

Fecal Microbiota Transplantation; Slow Transit Constipation; Randomized Controlled Trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fecal microbiota transplantation (FMT)

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.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation (FMT)

Intervention Type: DRUG

Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Conventional treatment

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Fecal microbiota transplantation (FMT)

Intervention Type: DRUG

Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Conventional treatment

Intervention Type: 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.

Interventions

Fecal microbiota transplantation (FMT)

Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.

Intervention Type: DRUG

Conventional treatment

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Fecal bacteriotherapy

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Gong

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianfeng Gong, MD

Role: CONTACT

Phone: +86-25-80860036

Email: jinlingh_gongjf@126.com

Ning Li, MD

Role: CONTACT

Phone: +86-25-80860089

Email: jinlingh_lining@126.com

Facility Contacts

Ning Li, MD

Role: primary

Other Identifiers

RCT-FMT-STC-2015

Identifier Type: -

Identifier Source: org_study_id