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Effect of Fecal Microbiota Transplantation in Slow Transit Constipation (FMTSTC)

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ClinicalTrials.gov Identifier: NCT02301221
Recruitment Status : Unknown
Verified November 2016 by Jianfeng Gong, Jinling Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : November 4, 2016
Sponsor:
Information provided by (Responsible Party):
Jianfeng Gong, Jinling Hospital, China

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

Condition or disease Intervention/treatment Phase
Slow Transit Constipation Procedure: Fecal microbiota transplantation (FMT) Drug: Vancomycin and bowel lavage Phase 2

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 our 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, we suppose that reshaping the gut microbiome with FMT would be effective for patients with slow transit constipation.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Efficacy, Safety and Durability of Fecal Microbiota Transplantation in Adult Patients With Slow Transit Constipation
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Vancomycin

Arm Intervention/treatment
Experimental: Fecal microbiota transplantation (FMT)
Patients included will receive standard FMT, and then will be followed up for 24 weeks.
Procedure: Fecal microbiota transplantation (FMT)
Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
Other Name: Fecal bacteriotherapy

Drug: Vancomycin and bowel lavage
An initial vancomycin regimen (500 mg orally two times per day for 3 days), followed by bowel lavage before the infusion of a solution of donor fecal microbiota.




Primary Outcome Measures :
  1. Proportion of patients having on average three or more SCBMs/week [ Time Frame: 24 weeks ]
    Proportion of patients having on average three or more spontaneous, complete bowel movements (SCBMs) per week was evaluated at baseline and over the week interval 3-4, 9-12 and 21-24.


Secondary Outcome Measures :
  1. Bowel habit assessments [ Time Frame: 24 weeks ]
    Patients kept daily diaries about times of bowel movements each day, stool consistency, degree of straining severity during defecation, and degree of sensation of incompleteness of evacuation.

  2. Constipation-related symptoms assessments [ Time Frame: 24 weeks ]
    Constipation-related symptoms were evaluated using the validated Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire at baseline and at week 4, 12, and 24.

  3. Quality-of-Life assessments [ Time Frame: 24 weeks ]
    Quality-of-Life was evaluated using the validated Patient Assessment of Constipation Quality of Life (PAC-QOL) self-report questionnaire at baseline and at week 4, 12, and 24.

  4. Colonic transit time measurements [ Time Frame: 24 weeks ]
    Colonic transit time (CTT) was measured at baseline and at week 4, 12 and 24 with the Metcalf method.

  5. Usage of laxatives or enemas as rescue medication [ Time Frame: 24 weeks ]
    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 were used. Patients kept daily diaries about the rescue medication when used.

  6. Adverse events [ Time Frame: 24 weeks ]
    Adverse events include fever, diarrhea, abdominal pain, increased bloating, borborygmi, flatulence, nausea, vomiting, nasopharyngitis, and any other disorders.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301221


Locations
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China, Jiangsu
Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China
Investigators
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Study Director: Ning Li, MD Department of Generay Surgery, Jinling hosptal

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Responsible Party: Jianfeng Gong, Associate professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02301221     History of Changes
Other Study ID Numbers: RIGS-FMT-STC-2014
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016

Keywords provided by Jianfeng Gong, Jinling Hospital, China:
Fecal Microbiota Transplantation
Slow Transit Constipation
Colonic motility

Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents