RCE With FMT in the Treatment of Childhood Constipation

Fecal Microbiota Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035784
• Other study ID #: A333--1
• Status: Completed
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: May 13, 2022

Study information

• Verified date: November 2023
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: May 13, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional
• Fecal Microbiota Transplantation

Intervention

Drug:
• Fecal supernatant
Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .
• Placebo
a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of spontaneous bowel movements(SBMs) per week	the frequency of defecation without drugs or other auxiliary methods	Baseline
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Bowel movements	the frequency of bowel movements per week	Baseline
Secondary	Bowel movements	the frequency of bowel movements per week	at the end of 4-weeks FMT treatment
Secondary	Bowel movements	the frequency of bowel movements per week	at the end of 12 weeks follow-up
Secondary	Painful or hard bowel movements	The feelings of children during defecation	Baseline
Secondary	Painful or hard bowel movements	The feelings of children during defecation	at the end of 4-weeks FMT treatment
Secondary	Painful or hard bowel movements	The feelings of children during defecation	at the end of 12 weeks follow-up
Secondary	Large diameter or scybalous stools	appearance and wetness of stool	Baseline
Secondary	Large diameter or scybalous stools	appearance and wetness of stool	at the end of 4-weeks FMT treatment
Secondary	Large diameter or scybalous stools	appearance and wetness of stool	at the end of 12 weeks follow-up
Secondary	Excessive volitional stool retention	The number of children who intentionally control or reduce the frequency of defecation	Baseline
Secondary	Excessive volitional stool retention	The number of children who intentionally control or reduce the frequency of defecation	at the end of 4-weeks FMT treatment
Secondary	Excessive volitional stool retention	The number of children who intentionally control or reduce the frequency of defecation	at the end of 12 weeks follow-up
Secondary	Encopresis	the frequency of fecal incontinence	Baseline
Secondary	Encopresis	the frequency of fecal incontinence	at the end of 4-weeks FMT treatment
Secondary	Encopresis	the frequency of fecal incontinence	at the end of 12 weeks follow-up