ClinicalTrials.gg
Sign In
RecruitingNCT06785844Updated Jun 18, 2026

Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study

An Early Phase 1 interventional study of Botulinum Toxin A (Botox ) in Fecal Incontinence, sponsored by Shaare Zedek Medical Center. Recruiting at 1 site in Israel. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by Shaare Zedek Medical Center · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 4 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
4 Years to 18 Years
Sex
All
01

Study summary

Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.

Objectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.

Methods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.

Significance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.

02

Conditions studied

  • Fecal Incontinence

Browse trials for

03

In context

Fecal Incontinence

283 studies on the registry are indexed under Fecal Incontinence; 52 are open to participants now.

This study's planned enrollment of 14 is below the median of 50 across 203 interventional studies indexed under Fecal Incontinence.

Browse Fecal Incontinence studies →

Lead sponsor

Shaare Zedek Medical Center is the lead sponsor of 195 studies on the registry; 19 are open to participants now.

Browse Shaare Zedek Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children 4-18 years old with fecal incontinence for a period greater than 6 months.
  • FI frequency of ≥ 3 episodes/week.
  • After appropriate medical evaluation, FI cannot be explained by another medical condition.
  • Normal colonic transit study, defined as passage of 80% of markers on day
  • Normal RAIR on anorectal manometry

Exclusion criteria

Exclusion Criteria:

  • Patients currently fulfilling rome IV criteria for functional constipation.
  • Patients with evidence of fecal retention.
  • Patients who had had good response to treatment for overflow incontinence.
  • Absent RAIR on anorectal manometry.
  • Any radiologic evidence of dochylosigmoid or distended colon.
  • Any known organic condition that may affect bowel transit.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Botulinum toxin

    Drug: Botulinum Toxin A (Botox )

Interventions

06

What researchers measure

Primary outcomes

  1. median number of FI episodes/week at 1-month post-intervention compared to baseline

    median number of FI episodes/week at 1-month post-intervention compared to baseline. The median FI episodes/week will be calculated based on the 21-day diary. FI episode minimal definition: any episode of soiling requiring change of underwear/clothes/washing-up.

    Time frame: 3-months post-intervention

Secondary outcomes

  1. Median number of FI episodes/week at 3-months post-intervention, compared to baseline diary.

    Time frame: 3-months post-intervention

  2. Rate of patients with a 50% decrease in mean FI episodes/week compared to baseline diary.

    Time frame: 3-months post-intervention

  3. Rate of patients with daily FI episodes (at least 1 episode/day) compared to baseline.

    Time frame: 3-months post-intervention

  4. Mean number of complete bowel movements/week compared to baseline according to diary.

    Time frame: 3-months post-intervention

  5. Parents and patient's general impression of the treatment using the following questions: "Was the treatment useful/beneficial?"; "Did the treatment improve your quality of life"?

    Time frame: 3-months post-intervention

  6. Rate of RBI-associated major and minor adverse events. Patients will be questioned according to list, as well as allowed to add adverse events not listed.

    Time frame: 3-months post-intervention

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Rybak A, Martinelli M, Thapar N, Van Wijk MP, Vandenplas Y, Salvatore S, Staiano A, Benninga MA, Borrelli O. Colonic Function Investigations in Children: Review by the ESPGHAN Motility Working Group. J Pediatr Gastroenterol Nutr. 2022 May 1;74(5):681-692. doi: 10.1097/MPG.0000000000003429. Epub 2022 Feb 24. PubMed 35262513 ↗
  • Athanasakos E, Cleeve S, Thapar N, Lindley K, Perring S, Cronin H, Borrelli O, Mutalib M. Anorectal manometry in children with defecation disorders BSPGHAN Motility Working Group consensus statement. Neurogastroenterol Motil. 2020 Jun;32(6):e13797. doi: 10.1111/nmo.13797. Epub 2020 Jan 27. PubMed 31989766 ↗
  • Pascual-Pascual SI, Pascual-Castroviejo I. Safety of botulinum toxin type A in children younger than 2 years. Eur J Paediatr Neurol. 2009 Nov;13(6):511-5. doi: 10.1016/j.ejpn.2008.10.006. Epub 2008 Nov 25. PubMed 19036619 ↗
  • Halleran DR, Lu PL, Ahmad H, Paradiso MM, Lehmkuhl H, Akers A, Hallagan A, Bali N, Vaz K, Yacob D, Di Lorenzo C, Levitt MA, Wood RJ. Anal sphincter botulinum toxin injection in children with functional anorectal and colonic disorders: A large institutional study and review of the literature focusing on complications. J Pediatr Surg. 2019 Nov;54(11):2305-2310. doi: 10.1016/j.jpedsurg.2019.03.020. Epub 2019 Apr 23. PubMed 31060739 ↗
  • Leroi AM, Queralto M, Zerbib F, Siproudhis L, Vitton V, Amarenco G, Etienney I, Mion F, Bridoux V, Philip J, Brochard C, Damon H, Lacroix E, Gillibert A, Gourcerol G. Intrarectal injections of botulinum toxin versus placebo for the treatment of urge faecal incontinence in adults (FI-Toxin): a double-blind, multicentre, randomised, controlled phase 3 study. Lancet Gastroenterol Hepatol. 2024 Feb;9(2):147-158. doi: 10.1016/S2468-1253(23)00332-1. Epub 2023 Dec 18. PubMed 38128556 ↗
  • Kaul A, Garza JM, Connor FL, Cocjin JT, Flores AF, Hyman PE, Di Lorenzo C. Colonic hyperactivity results in frequent fecal soiling in a subset of children after surgery for Hirschsprung disease. J Pediatr Gastroenterol Nutr. 2011 Apr;52(4):433-6. doi: 10.1097/MPG.0b013e3181efe551. PubMed 21240024 ↗
  • 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. PubMed 31690829 ↗
  • de Bruijn CMA, Safder S, Rolle U, Mosiello G, Marshall D, Christiansen AB, Benninga MA. Development of a Bowel Management Scoring Tool in Pediatric Patients with Constipation. J Pediatr. 2022 May;244:107-114.e1. doi: 10.1016/j.jpeds.2022.01.036. Epub 2022 Feb 1. PubMed 35114289 ↗
  • Koppen IJ, von Gontard A, Chase J, Cooper CS, Rittig CS, Bauer SB, Homsy Y, Yang SS, Benninga MA. Management of functional nonretentive fecal incontinence in children: Recommendations from the International Children's Continence Society. J Pediatr Urol. 2016 Feb;12(1):56-64. doi: 10.1016/j.jpurol.2015.09.008. Epub 2015 Oct 21. PubMed 26654481 ↗
  • Popescu M, Mutalib M. Bowel transit studies in children: evidence base, role and practicalities. Frontline Gastroenterol. 2021 May 10;13(2):152-159. doi: 10.1136/flgastro-2020-101719. eCollection 2022. PubMed 35300467 ↗
  • Lambregts AP, Nieuwhof-Leppink AJ, Klijn AJ, Schroeder RPJ. Intravesical botulinum-A toxin in children with refractory non-neurogenic overactive bladder. J Pediatr Urol. 2022 Jun;18(3):351.e1-351.e8. doi: 10.1016/j.jpurol.2022.02.007. Epub 2022 Feb 18. PubMed 35283021 ↗
  • Voskuijl WP, Reitsma JB, van Ginkel R, Buller HA, Taminiau JA, Benninga MA. Longitudinal follow-up of children with functional nonretentive fecal incontinence. Clin Gastroenterol Hepatol. 2006 Jan;4(1):67-72. doi: 10.1016/j.cgh.2005.10.001. PubMed 16431307 ↗
  • Rajindrajith S, Devanarayana NM, Benninga MA. Review article: faecal incontinence in children: epidemiology, pathophysiology, clinical evaluation and management. Aliment Pharmacol Ther. 2013 Jan;37(1):37-48. doi: 10.1111/apt.12103. Epub 2012 Oct 28. PubMed 23106105 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2025 (actual). Primary completion is estimated for Sep 2030, 62 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2025
First posted
Jan 21, 2025
StartActual
Jul 1, 2025
Primary completionEst.
Sep 2030
CompletionEst.
Sep 2030
Last update
Jun 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06785844
Lead sponsor
Shaare Zedek Medical Center
Responsible party
Yogev Dotan (Dr Dotan Yogev, Shaare Zedek Medical Center) — Principal investigator
First posted
Jan 21, 2025
Start date
Jul 1, 2025
Primary completion
Sep 2030 (estimated)
Completion
Sep 2030 (estimated)
Last update
Jun 18, 2026

Study contacts

Dotan Yogev, MD
Contact
dotany@szmc.org
97225645027
Zivia Shavit, MSc
Contact
zivias@szmc.org.il
972542520204

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Botulinum toxin type A

Other studies in this condition

Fecal Incontinence →

Other studies from this sponsor

Shaare Zedek Medical Center →

Start the discussion