Rectal ProlapseEarly Phase 1NCT06174584
Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children
A Early Phase 1 study testing Hypertonic saline and Cow Milk in people with Rectal Prolapse, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- Hypertonic saline and Cow Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All children with Grade I and II rectal prolapse
- Age <12 years
- Both genders
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University/PIMS
Islamabad, 44000
About this study
To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children
Read the detailed description
Sclerotherapy is the least invasive procedure used in management of grade I/II rectal prolapse, with a success rate of around 80%, and generally considered as the first choice for uncomplicated and recurrent prolapse. Several sclerosing agents such as 15% hypertonic saline, 5% Phenol in almond oil and cow milk have been used and reported in the literature. Present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in the management of children with grade I/II rectal prolapse.
All the details will be entered on the proforma which will include resolvement of rectal prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal stenosis.
- Conditions
- Rectal Prolapse
- Being tested
- Hypertonic saline, Cow Milk
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineDrug
Hypertonic saline
Cow MilkOther
Cow Milk
| Study group | Role | What they receive |
|---|---|---|
| Cow Milk | Active comparator | Cow Milk was injected as sclerosing agent in one group Receives: Other: Cow Milk |
| 15% Hypertonic Saline | Active comparator | Hypertonic Saline 15% used as sclerosing agent in other half. Receives: Drug: Hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence (as described by parent s during follow up)
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Measured: 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
Measured: 1 year
Number of participants with anal stenosis (on clinical examination)
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start1 Feb 2021
- Primary completion30 Jan 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mansoor Ahmed, Shaheed Zulfiqar Ali Bhutto Medical University
- Investigators
- Mansoor Ahmed, MBBS, Principal investigator, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06174584
- Sponsor's protocol ID
- ShaheedZABMU1234
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children
- ClinicalTrials.gov ID
- NCT06174584
- Acronym / sponsor ID
- ShaheedZABMU1234
- Conditions
- Rectal Prolapse
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children
Detailed description
Sclerotherapy is the least invasive procedure used in management of grade I/II rectal prolapse, with a success rate of around 80%, and generally considered as the first choice for uncomplicated and recurrent prolapse. Several sclerosing agents such as 15% hypertonic saline, 5% Phenol in almond oil and cow milk have been used and reported in the literature. Present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in the management of children with grade I/II rectal prolapse.
All the details will be entered on the proforma which will include resolvement of rectal prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal stenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cow Milk | Active comparator | Other: Cow MilkCow Milk was injected as sclerosing agent in one group |
| 15% Hypertonic Saline | Active comparator | Drug: Hypertonic salineHypertonic Saline 15% used as sclerosing agent in other half. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All children with Grade I and II rectal prolapse
- Age <12 years
- Both genders
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic salineHypertonic saline | Drug | 15% Hypertonic Saline |
| Cow MilkCow Milk | Other | Cow Milk |
Primary outcome
recurrence (as described by parent s during follow up)
Time frame: 1 year
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Number of participants with fecal incontinence (as described by parents during follow up)
Time frame: 1 year
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Number of participants with anal stenosis (on clinical examination)
Time frame: 1 year
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No. Confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansoor Ahmed, MBBS principal investigator
Shaheed Zulfiqar Ali Bhutto Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Hypertonic saline and Cow Milk in people with Rectal Prolapse, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence (as described by parent s during follow up) (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.