Gastro-Intestinal ToleranceNCT01782456
Tolerance of an Oral Nutritional Supplement(ONS)
A study testing Study Oral Nutritional Supplement in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 1 site in United States.
Trial summary
The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years. Read more about this study
- Who is it for?
- Ages 3 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro-Intestinal Tolerance
- What is being tested?
- Study Oral Nutritional Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Apr 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 3 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age ≥ 3 and ≤ 10 years of age
- Healthy and not suffering from any physical disability.
- Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
- Consumption of 2 servings/day of the investigational product for 7 consecutive days
- Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
- Agreement to not consume a nutritional product that is not study product during the study period
Who cannot join
- History of an acute or chronic condition that may affect feeding habits or nutritional status
- Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
- Clinically significant nutritional deficiency requiring specific treatment
- Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
- History of constipation
- Allergy or intolerance to any ingredient in the study product
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- Gastrointestinal infection or acute diarrhea at the time of study start
- Hepatitis B or C, or HIV, or malignancy
- Congenital cardiac defects
- Antibiotic therapy within last 2 weeks of start of study
- Dysphagia, aspiration risk, difficulty in swallowing due to acquired/congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children
The objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.
- Conditions
- Gastro-Intestinal Tolerance
- Being tested
- Study Oral Nutritional Supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Oral Nutritional SupplementOther
Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
| Study group | Role | What they receive |
|---|---|---|
| Study Oral Nutritional Supplement | Experimental | 2 servings per day of a complete and balanced, ready-to-drink oral nutritional supplement with a new protein blend. Receives: Other: Study Oral Nutritional Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastro-Intestinal Tolerance
Self-reported Questionnaire
Measured: Study Day 1-7
Secondary outcomes (3)
Study Supplement Compliance
Self-reported number of servings consumed per day
Measured: Study Day 1-7
Weight
Measured: Study Day 1 and 8
Height
Measured: Study Day 1 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-Intestinal ToleranceStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, MPH, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782456
- Sponsor's protocol ID
- AL09
- Status last verified
- May 2013
- First submitted
- 31 Jan 2013
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of an Oral Nutritional Supplement(ONS)With a New Protein Blend in Healthy Children
- ClinicalTrials.gov ID
- NCT01782456
- Acronym / sponsor ID
- AL09
- Conditions
- Gastro-Intestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 4 Feb 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 objective of this study is to capture information on gastrointestinal tolerance (GI) of an oral nutritional supplement containing a new protein blend in healthy children aged ≥ 3 to ≤ 10 years.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Oral Nutritional Supplement | Experimental | Other: Study Oral Nutritional Supplement2 servings per day of a complete and balanced, ready-to-drink oral nutritional supplement with a new protein blend. |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age ≥ 3 and ≤ 10 years of age
- Healthy and not suffering from any physical disability.
- Height-for-age and BMI-for-age between the 5th and the 95th percentile as well as a weight-for-age between the 5th and the 85th percentile
- Consumption of 2 servings/day of the investigational product for 7 consecutive days
- Willingness to follow the study procedures and record the data in the diary and complete any forms or assessment as needed throughout the study
Key exclusion criteria (11 listed)
- History of an acute or chronic condition that may affect feeding habits or nutritional status
- Medications or nutritional supplements, taken on a daily basis for more than 2 weeks during the past month prior to screening visit that may profoundly affect feeding habits or nutritional status
- Clinically significant nutritional deficiency requiring specific treatment
- Acute/chronic condition requiring medical treatment which may include hospitalization such as diabetes or stress induced hyperglycemia, dialysis treatment, inflammatory bowel disease, pancreatitis, autoimmune disease or immunodeficiency, celiac disease, cystic fibrosis, active tuberculosis, malformation of the gastrointestinal tract or gastroesophageal reflux disease
- History of constipation
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 |
|---|---|---|
| Study Oral Nutritional SupplementSupplement contains a new protein mix consisting of a blend of milk, soy, and pea protein. | Other | Study Oral Nutritional Supplement |
Primary outcome
Gastro-Intestinal Tolerance
Time frame: Study Day 1-7
Self-reported Questionnaire
3 secondary outcomes
Study Supplement Compliance
Time frame: Study Day 1-7
Weight
Time frame: Study Day 1 and 8
Height
Time frame: Study Day 1 and 8
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 3 Jun 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.
Jennifer Williams, MPH study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Oral Nutritional Supplement in people with Gastro-Intestinal Tolerance, run by Abbott Nutrition at 1 site in United States.
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 11 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 3 Jun 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 United States. 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.
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?
Gastro-Intestinal Tolerance (time frame: Study Day 1-7). 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 3 Jun 2013.