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RCE With FMT in the Treatment of Childhood Constipation

NCT ID: NCT05035784

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2022-05-13

Brief Summary

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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.

Detailed Description

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Conditions

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Fecal Microbiota Transplantation Constipation - Functional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Fecal supernatant

Fecal supernatant is used for treatment of childhood Constipation

Group Type ACTIVE_COMPARATOR

Fecal supernatant

Intervention Type DRUG

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

non-Fecal supernatant

Placebo is used for treatment of childhood Constipation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Fecal supernatant

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shengjing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shucheng Zhang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shengjing Hospital

Shenyang, Liaoning, China

Site Status

Countries

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China

References

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Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016.

Reference Type BACKGROUND
PMID: 27529553 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31169545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30908299 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26751143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30809523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31665572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22002980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31690829 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27688650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28129018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28164849 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29358877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31639033 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38989869 (View on PubMed)

Other Identifiers

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A333--1

Identifier Type: -

Identifier Source: org_study_id