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Efficacy and Safety of Fecal Microbiota Transplantation for Slow Transit Constipation

This study is currently recruiting participants.
See Contacts and Locations
Verified November 2016 by Jianfeng Gong, Jinling Hospital, China
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China
ClinicalTrials.gov Identifier:
NCT02526849
First received: August 14, 2015
Last updated: November 3, 2016
Last verified: November 2016
  Purpose
The purpose of this study is to evaluate the effect of fecal microbiota transplantation in adults with slow transit constipation.

Condition Intervention Phase
Slow Transit Constipation Drug: Fecal microbiota transplantation (FMT) Behavioral: Conventional treatment Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation

Resource links provided by NLM:


Further study details as provided by Jianfeng Gong, Jinling Hospital, China:

Primary Outcome Measures:
  • Proportion of patients having on average three or more SCBMs/week [ Time Frame: 3 months ]
    Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at week 4 and 12.


Secondary Outcome Measures:
  • Mean number of bowel movements per week [ Time Frame: 3 months ]
    Patients kept daily diaries about times of bowel movements each day.

  • Characteristics of bowel movements [ Time Frame: 3 months ]
    Patients kept daily diaries about stool consistency and degree of straining severity during defecation.

  • Constipation-related symptoms assessments [ Time Frame: 3 months ]
    Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at week 4 and 12.

  • Quality-of-Life assessments [ Time Frame: 3 months ]
    Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at week 4 and 12.

  • Colonic transit time measurements [ Time Frame: 3 months ]
    Colonic transit time (CTT) was measured at week 4 and 12 with the Metcalf method.

  • Usage of laxatives or enemas as rescue medication [ Time Frame: 3 months ]
    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). If ineffective, enema was used. Patients kept daily diaries about the rescue medication when used.

  • Adverse events [ Time Frame: 3 months ]
    Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.


Estimated Enrollment: 100
Study Start Date: November 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Name: Fecal bacteriotherapy
Behavioral: 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.
Experimental: 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.
Drug: Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Name: Fecal bacteriotherapy
Behavioral: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02526849

Contacts
Contact: Jianfeng Gong, MD +86-25-80860036 jinlingh_gongjf@126.com
Contact: Ning Li, MD +86-25-80860089 jinlingh_lining@126.com

Locations
China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University Recruiting
Nanjing, Jiangsu, China, 210002
Contact: Ning Li, MD    +86-25-80860089    jinlingh_lining@126.com   
Principal Investigator: Jianfeng Gong, MD         
Sub-Investigator: Chao Ding, MD candidate         
Sponsors and Collaborators
Jinling Hospital, China
  More Information

Responsible Party: Jianfeng Gong, Associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02526849     History of Changes
Other Study ID Numbers: RCT-FMT-STC-2015
Study First Received: August 14, 2015
Last Updated: November 3, 2016

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Fecal Microbiota Transplantation
Slow Transit Constipation
Randomized Controlled Trial

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2017