Acute DiarrheaNCT01814202
Study With Medical Nutrition Product PTM202 in Pediatric Diarrhea
A study testing PTM202 in people with Acute Diarrhea, run by PanTheryx, Inc. at 1 site in Bangladesh.
Trial summary
The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Acute Diarrhea
- What is being tested?
- PTM202
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteBangladesh
- Study dates
- Mar 2013to Sep 2013
- Phase
- Interventional
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- males or females between 6 months and 5 years of age
- acute diarrhea (<48 hours) without interfering co-morbidities
- guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation
- Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase.
- Written informed consent must be obtained prior to admission to this study.
- The subject has a physical examination that reveals no clinically significant abnormalities other than those expected for subjects with acute infectious diarrhea.
Who cannot join
- Suspected or confirmed cholera
- Suspected dysentery
- Symptom duration >48 hours at screening
- Vomiting severity that is like to make administration and retention of test article impossible
- Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).
- Child already receiving antibiotics or anti-motility drugs for this diarrhea episode prior to screening.
- History of hypersensitivity or allergy to milk or egg
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)
Dhaka, Dhaka Division, 1212
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trial (Pilot Phase) to Evaluate the Efficacy of a Medical Nutrition Product, PTM202, in Children With Acute Diarrhea
The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children
- Conditions
- Acute Diarrhea
- Being tested
- PTM202, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTM202Other
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| PTM202 | Experimental | PTM202 is a medical nutrition product Receives: Other: PTM202 |
| Placebo | Placebo comparator | The placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
diarrhea duration
Measured: 7 days
Secondary outcomes (3)
food intake
Measured: 7 days
stool frequency
Measured: 7 days
stool consistency
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- PanTheryx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shafiqul A Sarker, MD, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814202
- Sponsor's protocol ID
- PTM.2012.002
- Other IDs
- PR-13002
- Status last verified
- Oct 2013
- First submitted
- 15 Mar 2013
- Last updated
- 7 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Clinical Trial (Pilot Phase) to Evaluate the Efficacy of a Medical Nutrition Product, PTM202, in Children With Acute Diarrhea
- ClinicalTrials.gov ID
- NCT01814202
- Acronym / sponsor ID
- PTM.2012.002
- Conditions
- Acute Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- PanTheryx, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Mar 2013 (estimated)
- 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.
The purpose of this study is to determine whether a medical nutrition product, PTM202, along with standard of care, enhances recovery and reduces diarrhea morbidity in young children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTM202 | Experimental | Other: PTM202PTM202 is a medical nutrition product |
| Placebo | Placebo comparator | Other: PlaceboThe placebo is a placebo for PTM202, a food product that can not be distinguished from PTM202 by appearance, taste or odor |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- males or females between 6 months and 5 years of age
- acute diarrhea (<48 hours) without interfering co-morbidities
- guardian willing to have child admitted to hospital as an inpatient for 96 hours and to return to the clinic with the child on Day 7 for a final evaluation
- Guardian is willing and able to report to the Investigator information on stool frequency, stool consistency and food and water intakes during the follow up phase.
- Written informed consent must be obtained prior to admission to this study.
Key exclusion criteria (7 listed)
- Suspected or confirmed cholera
- Suspected dysentery
- Symptom duration >48 hours at screening
- Vomiting severity that is like to make administration and retention of test article impossible
- Severe malnutrition (defined as weight for height of less than -3 SD below median, per WHO Standards (6).
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 |
|---|---|---|
| PTM202 | Other | PTM202 |
| Placebo | Other | Placebo |
Primary outcome
diarrhea duration
Time frame: 7 days
3 secondary outcomes
food intake
Time frame: 7 days
stool frequency
Time frame: 7 days
stool consistency
Time frame: 7 days
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 7 Oct 2013.
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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.
Shafiqul A Sarker, MD principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTM202 in people with Acute Diarrhea, run by PanTheryx, Inc. at 1 site in Bangladesh.
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 6 inclusion and 7 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 7 Oct 2013. 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 Bangladesh. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
diarrhea duration (time frame: 7 days). 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 7 Oct 2013.