RCE With FMT in the Treatment of Childhood Constipation

NCT05035784 | Completed

• 1 other identifier: A333--1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fecal Microbiota Transplantation; Constipation - Functional

Outcome Measures

Primary Outcomes (6)

• improvement of spontaneous bowel movements(SBMs) per week

  the frequency of defecation without drugs or other auxiliary methods

  Baseline

• improvement of spontaneous bowel movements(SBMs) per week

  the frequency of defecation without drugs or other auxiliary methods

  at the end of 4-weeks FMT treatment

• improvement of spontaneous bowel movements(SBMs) per week

  the frequency of defecation without drugs or other auxiliary methods

  at the end of 12 weeks follow-up

• Satisfaction with bowel function

  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).

  Baseline

• Satisfaction with bowel function

  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).

  at the end of 4-weeks FMT treatment

• Satisfaction with bowel function

  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).

  at the end of 12 weeks follow-up

Secondary Outcomes (15)

• Bowel movements

  Baseline

• Bowel movements

  at the end of 4-weeks FMT treatment

• Bowel movements

  at the end of 12 weeks follow-up

• Painful or hard bowel movements

  Baseline

• Painful or hard bowel movements

  at the end of 4-weeks FMT treatment

Study Arms (2)

Fecal supernatant

ACTIVE COMPARATOR

Fecal supernatant is used for treatment of childhood Constipation

Drug: Fecal supernatant

non-Fecal supernatant

PLACEBO COMPARATOR

Placebo is used for treatment of childhood Constipation

Drug: Placebo

Interventions

Fecal supernatant DRUG

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

Fecal supernatant

Placebo DRUG

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

non-Fecal supernatant

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

Related Publications (14)

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  PMID: 27529553 BACKGROUND

• Gurram B, Sue PK. Fecal microbiota transplantation in children: current concepts. Curr Opin Pediatr. 2019 Oct;31(5):623-629. doi: 10.1097/MOP.0000000000000787.

  PMID: 31169545 BACKGROUND

• Xu D, Chen VL, Steiner CA, Berinstein JA, Eswaran S, Waljee AK, Higgins PDR, Owyang C. Efficacy of Fecal Microbiota Transplantation in Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis. Am J Gastroenterol. 2019 Jul;114(7):1043-1050. doi: 10.14309/ajg.0000000000000198.

  PMID: 30908299 BACKGROUND

• Tian H, Ding C, Gong J, Ge X, McFarland LV, Gu L, Wei Y, Chen Q, Zhu W, Li J, Li N. Treatment of Slow Transit Constipation With Fecal Microbiota Transplantation: A Pilot Study. J Clin Gastroenterol. 2016 Nov/Dec;50(10):865-870. doi: 10.1097/MCG.0000000000000472.

  PMID: 26751143 BACKGROUND

• Ohkusa T, Koido S, Nishikawa Y, Sato N. Gut Microbiota and Chronic Constipation: A Review and Update. Front Med (Lausanne). 2019 Feb 12;6:19. doi: 10.3389/fmed.2019.00019. eCollection 2019.

  PMID: 30809523 BACKGROUND

• Kassam Z, Dubois N, Ramakrishna B, Ling K, Qazi T, Smith M, Kelly CR, Fischer M, Allegretti JR, Budree S, Panchal P, Kelly CP, Osman M. Donor Screening for Fecal Microbiota Transplantation. N Engl J Med. 2019 Nov 21;381(21):2070-2072. doi: 10.1056/NEJMc1913670. Epub 2019 Oct 30. No abstract available.

  PMID: 31665572 BACKGROUND

• Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011 Nov;53(10):994-1002. doi: 10.1093/cid/cir632.

  PMID: 22002980 BACKGROUND

• Vriesman MH, Koppen IJN, Camilleri M, Di Lorenzo C, Benninga MA. Management of functional constipation in children and adults. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):21-39. doi: 10.1038/s41575-019-0222-y. Epub 2019 Nov 5.

  PMID: 31690829 BACKGROUND

• Clemente MG, Mandato C, Poeta M, Vajro P. Pediatric non-alcoholic fatty liver disease: Recent solutions, unresolved issues, and future research directions. World J Gastroenterol. 2016 Sep 28;22(36):8078-93. doi: 10.3748/wjg.v22.i36.8078.

  PMID: 27688650 BACKGROUND

• Woodworth MH, Carpentieri C, Sitchenko KL, Kraft CS. Challenges in fecal donor selection and screening for fecal microbiota transplantation: A review. Gut Microbes. 2017 May 4;8(3):225-237. doi: 10.1080/19490976.2017.1286006. Epub 2017 Jan 27.

  PMID: 28129018 BACKGROUND

• Vindigni SM, Surawicz CM. Fecal Microbiota Transplantation. Gastroenterol Clin North Am. 2017 Mar;46(1):171-185. doi: 10.1016/j.gtc.2016.09.012.

  PMID: 28164849 BACKGROUND

• Shen ZH, Zhu CX, Quan YS, Yang ZY, Wu S, Luo WW, Tan B, Wang XY. Relationship between intestinal microbiota and ulcerative colitis: Mechanisms and clinical application of probiotics and fecal microbiota transplantation. World J Gastroenterol. 2018 Jan 7;24(1):5-14. doi: 10.3748/wjg.v24.i1.5.

  PMID: 29358877 BACKGROUND

• Dai M, Liu Y, Chen W, Buch H, Shan Y, Chang L, Bai Y, Shen C, Zhang X, Huo Y, Huang D, Yang Z, Hu Z, He X, Pan J, Hu L, Pan X, Wu X, Deng B, Li Z, Cui B, Zhang F. Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients. Crit Care. 2019 Oct 21;23(1):324. doi: 10.1186/s13054-019-2604-5.

  PMID: 31639033 BACKGROUND

• Gu X, Yang Z, Kou Y, Yang F, Wang Y, Chen Y, Wang E, Jiang X, Bai Y, Zhang Z, Zhang S. Effects of Retrograde Colonic Enema-Based Fecal Microbiota Transplantation in the Treatment of Childhood Constipation: A Randomized, Double-Blind, Controlled Trial. Am J Gastroenterol. 2024 Nov 1;119(11):2288-2297. doi: 10.14309/ajg.0000000000002958. Epub 2024 Jul 11.

  PMID: 38989869 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 5, 2021
• Study Start: November 10, 2020
• Primary Completion: January 20, 2022
• Study Completion: May 13, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

CN (1)