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Completed

NCT Number: NCT05035784

RCE With FMT in the Treatment of Childhood Constipation

Constipation is the most common complaint in childhood gastrointestinal disease, affecting an estimated 20% of the global children.The treatment strategies consist of diet control, behavioral intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects, the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, and the use of PEG increases the risk of fecal incontinence. Additional treatment interventions are still necessary.Enema can act directly on the rectum and distal colon to quickly relieve symptoms of fecal impaction which is considered one of main source of intractable constipation. Children with fecal impaction who received enema had fewer fecal incontinence and diarrhea than children who received PEG. There have been lots of evidence that enema is effective in fecal impaction in children with functional constipation.But there are still cases of recurrences noted after enema. Fecal bacteria transplantation (FMT) is a new treatment method emerging in recent years, which is widely used in the treatment of functional gastrointestinal diseases. FMT has been proved to play a very prominent role in correcting intestinal flora disorders. By transplanting exogenous flora into the intestinal tract of patients, FMT can inhibit bacterial reproduction, regulate intestinal environment and cascade the body immunity, so as to achieve the therapeutic effect of disease.

Retrograde colonic enema with FMT, an new method, provides the possibility for the treatment of childhood constipation. However, there is still a lack of evidence-based support for the treatment of childhood constipation by retrograde colonic enema with FMT. Therefore, we designed a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of retrograde colonic enema with FMT in the treatment of childhood constipation.

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Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 4-14 years old;
  • Roman IV criteria for childhood constipation;
  • After a course of PEG and a course of Chinese medicine treatment was ineffective;
  • Barium enema showing fecal impaction.

Exclusion criteria

  • Congenital and/or acquired intestinal diseases, such as congenital megacolon, intestinal stenosis, polyps, Crohn's disease, tuberculosis, inflammation, and tumors;
  • Anorectal diseases, such as anal atresia, fistula, abscess, and tumor;
  • Neurological diseases, such as brain and spinal cord diseases;
  • genetic metabolic diseases;
  • psychosocial and behavioral diseases;
  • other systemic diseases;
  • Refused to participate in.

Treatment and study plan

Fecal supernatant

Drug

Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .

Placebo

Drug

a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.

Primary outcomes

  1. improvement of spontaneous bowel movements(SBMs) per week

    Time frame: Baseline

    the frequency of defecation without drugs or other auxiliary methods

  2. improvement of spontaneous bowel movements(SBMs) per week

    Time frame: at the end of 4-weeks FMT treatment

    the frequency of defecation without drugs or other auxiliary methods

  3. improvement of spontaneous bowel movements(SBMs) per week

    Time frame: at the end of 12 weeks follow-up

    the frequency of defecation without drugs or other auxiliary methods

  4. Satisfaction with bowel function

    Time frame: Baseline

    Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).

  5. Satisfaction with bowel function

    Time frame: at the end of 4-weeks FMT treatment

    Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).

  6. Satisfaction with bowel function

    Time frame: at the end of 12 weeks follow-up

    Satisfaction with bowel function was collected from the parents and defined as whether they were satisfied with bowel function after the treatment (yes or no).

Secondary outcomes

  1. Bowel movements

    Time frame: Baseline

    the frequency of bowel movements per week

  2. Bowel movements

    Time frame: at the end of 4-weeks FMT treatment

    the frequency of bowel movements per week

  3. Bowel movements

    Time frame: at the end of 12 weeks follow-up

    the frequency of bowel movements per week

  4. Painful or hard bowel movements

    Time frame: Baseline

    The feelings of children during defecation

  5. Painful or hard bowel movements

    Time frame: at the end of 4-weeks FMT treatment

    The feelings of children during defecation

  6. Painful or hard bowel movements

    Time frame: at the end of 12 weeks follow-up

    The feelings of children during defecation

  7. Large diameter or scybalous stools

    Time frame: Baseline

    appearance and wetness of stool

  8. Large diameter or scybalous stools

    Time frame: at the end of 4-weeks FMT treatment

    appearance and wetness of stool

  9. Large diameter or scybalous stools

    Time frame: at the end of 12 weeks follow-up

    appearance and wetness of stool

  10. Excessive volitional stool retention

    Time frame: Baseline

    The number of children who intentionally control or reduce the frequency of defecation

  11. Excessive volitional stool retention

    Time frame: at the end of 4-weeks FMT treatment

    The number of children who intentionally control or reduce the frequency of defecation

  12. Excessive volitional stool retention

    Time frame: at the end of 12 weeks follow-up

    The number of children who intentionally control or reduce the frequency of defecation

  13. Encopresis

    Time frame: Baseline

    the frequency of fecal incontinence

  14. Encopresis

    Time frame: at the end of 4-weeks FMT treatment

    the frequency of fecal incontinence

  15. Encopresis

    Time frame: at the end of 12 weeks follow-up

    the frequency of fecal incontinence

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

Retrograde Colonic Enema With Fecal Microbiota Transplantation vs Retrograde Colonic Enema Only in the Treatment of Childhood Constipation

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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