NCT06174584

Brief Summary

To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2021

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

November 28, 2023

Last Update Submit

December 15, 2023

Conditions

Rectal Prolapse

Outcome Measures

Primary Outcomes (3)

  • recurrence (as described by parent s during follow up)

    Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse

    1 year

  • Number of participants with fecal incontinence (as described by parents during follow up)

    Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse

    1 year

  • Number of participants with anal stenosis (on clinical examination)

    Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse

    1 year

Study Arms (2)

Cow Milk

ACTIVE COMPARATOR

Cow Milk was injected as sclerosing agent in one group

Other: Cow Milk

15% Hypertonic Saline

ACTIVE COMPARATOR

Hypertonic Saline 15% used as sclerosing agent in other half.

Drug: Hypertonic saline

Interventions

Hypertonic salineDRUG

Hypertonic saline

15% Hypertonic Saline
Cow MilkOTHER

Cow Milk

Cow Milk

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • All children with Grade I and II rectal prolapse
  • Age \<12 years
  • Both genders

You may not qualify if:

  • Rectal prolapse secondary to causes like ulcerative colitis and crohn's disease
  • Past surgical history on the pelvic floor,
  • Neurological diseases like rectal polyps, congenital megacolon, Hirschsprung disease, sacrococcygeal teratoma, neural tube defects, cauda equina syndrome
  • Where parents are not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Rectal Prolapse

Interventions

Saline Solution, HypertonicMilk

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Mansoor Ahmed, MBBS

    Shaheed Zulfiqar Ali Bhutto Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 28, 2023

First Posted

December 18, 2023

Study Start

February 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 1, 2022

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Confidentiality

Locations

PA(1)