DiarrheaNCT02385773
Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
A study testing PTM202 and Enfamil Puramino in people with Diarrhea, run by University of Colorado, Denver at 2 sites in Guatemala.
Trial summary
This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will enroll children between the ages of 6 months and 3 years and will assess the impact of the study nutrition product on the duration and… Read more about this study
- Who is it for?
- Ages 12 to 35 months
- Conditions the study is for
- Diarrhea
- What is being tested?
- PTM202 and Enfamil Puramino
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 2 sitesGuatemala
- Study dates
- Mar 2015to Jul 2016
- 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 12 to 35 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject's parent or legal guardian is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 6 months to 35 months.
- Presenting to care for acute diarrhea of 72 hours duration or less at the time of enrollment.
- Greater than 3 liquid stools in the previous 24 hours.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
- Additional inclusion for Arm 1: in addition to above, the subject will require or have already required > 8 hours of active rehydration in hospital or ER diarrheal ward, as determined by the attending physician.
- Additional inclusion for Arm 2: in addition to above, the subject will require or have already required < 8 hours of active rehydration in hospital or ER diarrheal ward, as determined by the attending physician.
Who cannot join
- Clinical condition for which oral intake of test product or placebo is contraindicated in opinion or attending physician.
- History of hypersensitivity or adverse reaction to milk or egg products.
- Condition improving in last 24 hours per parental report.
- Mild disease severity, defined as no recommended period of observed rehydration therapy per attending physician.
- Bloody Diarrhea at presentation.
- Severe malnutrition, defined as weight-for-age Z-score < -3 from median WHO published norms.
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- Major congenital defects or serious chronic illness (neurologic, pulmonary, gastrointestinal liver, renal or endocrine).
- Receipt of probiotics in 72 hours prior to enrollment or recommended treatment with probiotics by attending physician
- Any confirmed or suspected immunosuppressive or immunodeficient condition including human immunodeficiency virus infection (HIV).
- Subject who, in the opinion of the investigator or sub-investigator, is unlikely to comply with the protocol, including capability to receive follow-up telephone calls or return for final visit.
Trial locations and contacts
2 sites in 1 country.
Guatemala2 sites
Clínicas del Centro de Desarrollo Humano
Coatepeque
Hospital Roosevelt
Guatemala City
About this study
Official title: A Double Blind, Randomized, Placebo-Controlled Trial to Assess the Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will enroll children between the ages of 6 months and 3 years and will assess the impact of the study nutrition product on the duration and severity of diarrhea and on weight recovery in the 4 weeks following the diarrheal episode. The investigators will be determining the etiology of the diarrhea episode to ascertain if the nutritional product works better for certain etiologies or has a non-specific benefit.
Read the detailed description
This is a double-blind, randomized control trial of the nutritional product PTM202, which is a food product based on cow milk colostrum and eggs from hens that have been immunized against human diarrheal pathogens. Children between the ages of 6 months and 3 years will be enrolled at two sites in Guatemala who present with acute diarrhea. The study will have two strata according to the severity of the diarrhea.
The study product will be administered over 3 days, and the investigators will assess the impact on diarrhea duration and severity, and then follow subjects for 4 weeks to assess the impact of the nutritional product on weight gain following the episode, because poor weight gain is a major health problem in low-income countries. The investigators will also monitor for any adverse events during the trial.
The duration of participation will be 31 days for all subjects.
A stool sample will be collected at enrollment to ascertain the etiology of the diarrhea. A second sample will be collected at the end of the study to assess changes in pathogens.
- Conditions
- Diarrhea
- Being tested
- PTM202, Enfamil Puramino
- Keywords
- colostrum, Immunoglobulin Y (IgY)
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTM202Dietary supplement
Also called Conforta123
Administration of study nutritional product once per day for 3 days starting immediately after enrollment
Enfamil PuraminoDietary supplement
Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
| Study group | Role | What they receive |
|---|---|---|
| PTM202 | Experimental | PTM202 Receives: Dietary Supplement: PTM202 |
| Enfamil Puramino | Placebo comparator | Formal Placebo Receives: Dietary Supplement: Enfamil Puramino |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
Duration in hours until subject has achieved a 12 hour period without diarrheal stools
Measured: Subjects will be followed for the duration of the diarrheal illness, with an expected average duration of 72 hours
Secondary outcomes (2)
Weight gain after diarrhea
Weight will be assessed 14 days after the day 3 rehydrated baseline weight
Measured: 2 weeks
Weight gain after diarrhea
Weight will be assessed 28 days after the day 3 rehydrated baseline weight
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- PanTheryx, Inc.
- Responsible party
- Sponsor
- Investigators
- James T Gaensbauer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385773
- Sponsor's protocol ID
- 14-1372
- Status last verified
- Jan 2017
- First submitted
- 6 Feb 2015
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gaensbauer JT, Melgar MA, Calvimontes DM, Lamb MM, Asturias EJ, Contreras-Roldan IL, Dominguez SR, Robinson CC, Berman S. Efficacy of a bovine colostrum and egg-based intervention in acute childhood diarrhoea in Guatemala: a randomised, double-blind, placebo-controlled trial. BMJ Glob Health. 2017 Dec 4;2(4):e000452. doi: 10.1136/bmjgh-2017-000452. eCollection 2017.
PubMed 29259822
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo-Controlled Trial to Assess the Impact of the Nutritional Product PTM202 on Acute and Long-Term Recovery From Childhood Diarrheal Disease
- ClinicalTrials.gov ID
- NCT02385773
- Acronym / sponsor ID
- 14-1372
- Conditions
- Diarrhea
- Keywords
- colostrum, Immunoglobulin Y (IgY)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- PanTheryx, Inc.
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Mar 2015 (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.
This trial will assess the impact of the nutritional product PTM202 on childhood diarrhea in Guatemalan children. The product is based on cow-milk colostrum and egg. The trial will enroll children between the ages of 6 months and 3 years and will assess the impact of the study nutrition product on the duration and severity of diarrhea and on weight recovery in the 4 weeks following the diarrheal episode. The investigators will be determining the etiology of the diarrhea episode to ascertain if the nutritional product works better for certain etiologies or has a non-specific benefit.
Detailed description
This is a double-blind, randomized control trial of the nutritional product PTM202, which is a food product based on cow milk colostrum and eggs from hens that have been immunized against human diarrheal pathogens. Children between the ages of 6 months and 3 years will be enrolled at two sites in Guatemala who present with acute diarrhea. The study will have two strata according to the severity of the diarrhea.
The study product will be administered over 3 days, and the investigators will assess the impact on diarrhea duration and severity, and then follow subjects for 4 weeks to assess the impact of the nutritional product on weight gain following the episode, because poor weight gain is a major health problem in low-income countries. The investigators will also monitor for any adverse events during the trial.
The duration of participation will be 31 days for all subjects.
A stool sample will be collected at enrollment to ascertain the etiology of the diarrhea. A second sample will be collected at the end of the study to assess changes in pathogens.
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 | Dietary Supplement: PTM202PTM202 |
| Enfamil Puramino | Placebo comparator | Dietary Supplement: Enfamil PuraminoFormal Placebo |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subject's parent or legal guardian is willing and able to give informed consent for participation in the trial.
- Male or Female, aged 6 months to 35 months.
- Presenting to care for acute diarrhea of 72 hours duration or less at the time of enrollment.
- Greater than 3 liquid stools in the previous 24 hours.
- In the Investigator's opinion, is able and willing to comply with all trial requirements.
Key exclusion criteria (10 listed)
- Clinical condition for which oral intake of test product or placebo is contraindicated in opinion or attending physician.
- History of hypersensitivity or adverse reaction to milk or egg products.
- Condition improving in last 24 hours per parental report.
- Mild disease severity, defined as no recommended period of observed rehydration therapy per attending physician.
- Bloody Diarrhea at presentation.
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 |
|---|---|---|
| PTM202Also: Conforta123Administration of study nutritional product once per day for 3 days starting immediately after enrollment | Dietary supplement | PTM202 |
| Enfamil PuraminoAdministration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment | Dietary supplement | Enfamil Puramino |
Primary outcome
Duration of diarrhea
Time frame: Subjects will be followed for the duration of the diarrheal illness, with an expected average duration of 72 hours
Duration in hours until subject has achieved a 12 hour period without diarrheal stools
2 secondary outcomes
Weight gain after diarrhea
Time frame: 2 weeks
Weight gain after diarrhea
Time frame: 4 weeks
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 6 Jan 2017.
- Derived from this study: PubMed 29259822Gaensbauer JT, Melgar MA, Calvimontes DM, Lamb MM, Asturias EJ, Contreras-Roldan IL, Dominguez SR, Robinson CC, Berman S. Efficacy of a bovine colostrum and egg-based intervention in acute childhood diarrhoea in Guatemala: a randomised, double-blind, placebo-controlled trial. BMJ Glob Health. 2017 Dec 4;2(4):e000452. doi: 10.1136/bmjgh-2017-000452. eCollection 2017.
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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.
James T Gaensbauer, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PTM202 and Enfamil Puramino in people with Diarrhea, run by University of Colorado, Denver at 2 sites in Guatemala.
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 7 inclusion and 10 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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Guatemala. 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?
Duration of diarrhea (time frame: Subjects will be followed for the duration of the diarrheal illness, with an expected average duration of 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02385773, which also lists 1 linked publication.
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 6 Jan 2017.