Functional Gastrointestinal DisordersNCT03390309
Evaluation of A Partially Hydrolyzed in Improving FGIDs Symptoms
A study testing Partially Hydrolyzed Formula and Normal Formula in people with Functional Gastrointestinal Disorders, run by Children's Hospital of Fudan University.
Trial summary
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Functional Gastrointestinal Disorders
- What is being tested?
- Partially Hydrolyzed Formula and Normal Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2018to 28 Jun 2019
- 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 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
- Infant is between 30-180 days of age.
- Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
Who cannot join
- Complementary food was added for infants or parents are willing to add complementary food during study.
- Suffer from infection/illness.
- Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- Infant has visible bloody stools (detected before enrollment) prior to enrollment.
- Participation in another study.
About this study
Official title: Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Read the detailed description
This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.
- Conditions
- Functional Gastrointestinal Disorders
- Being tested
- Partially Hydrolyzed Formula, Normal Formula
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially Hydrolyzed FormulaOther
Partially Hydrolyzed Whey Protein Infant Formula
Normal FormulaOther
Normal Formula
| Study group | Role | What they receive |
|---|---|---|
| Partially Hydrolyzed Formula | Other | Infant was identified and got 1 or more scores by using infant feeding \& stool pattern questionnaire at Visit 1 will be assigned into experimental group randomly Receives: Other: Partially Hydrolyzed Formula |
| Normal Formula | Placebo comparator | Normal Formula Receives: Other: Normal Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of total symptom score of infant feeding & stool pattern questionnaire.
Investigator report questionnaire. Total score consists of 6 sub scores based on different symptom scaleing : diarrhea(0= no; 1= yes), constipation(0= no; 1= yes), galactorrhea/spit milk(0= no; 1= yes), Irritability or crying(0= no; 0.5= yes), bloating/ tummy drum/ exhaust(0= no; 1= yes), other(0= no, 0.5=yes).
Measured: From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start5 Jul 2018 (estimated)
- Primary completion30 Dec 2018 (estimated)
- Study completion28 Jun 2019 (estimated)
Why it stopped: no funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390309
- Sponsor's protocol ID
- Fudan-AN 001
- Status last verified
- Jul 2018
- First submitted
- 26 Nov 2017
- Last updated
- 12 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
- ClinicalTrials.gov ID
- NCT03390309
- Acronym / sponsor ID
- Fudan-AN 001
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 5 Jul 2018 (estimated)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 28 Jun 2019 (estimated)
- First posted
- 4 Jan 2018 (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.
Evaluation of A Partially Hydrolyzed Whey Protein Infant Formula in Improving Functional Gastrointestinal Disorders (FGIDs) Symptoms
Detailed description
This study will investigate the prevalence of Shanghai area's infant with FGIDs symptom and contrast for the FGIDs symptoms by using different intervention means, and evaluate the effectiveness of FGIDs symptoms in infants by using partially hydrolyzed whey protein and low lactose infant formulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partially Hydrolyzed Formula | Other | Other: Partially Hydrolyzed FormulaInfant was identified and got 1 or more scores by using infant feeding \& stool pattern questionnaire at Visit 1 will be assigned into experimental group randomly |
| Normal Formula | Placebo comparator | Other: Normal FormulaNormal Formula |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants is formula-fed or mixed feeding a cow milk protein-based formula for less 7 days prior to enrollment.
- Infant is between 30-180 days of age.
- Infant's parent(s) or Legally authorized representative(LAR) has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) prior to any participation in the study.
Key exclusion criteria (5 listed)
- Complementary food was added for infants or parents are willing to add complementary food during study.
- Suffer from infection/illness.
- Infant has suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- Infant has visible bloody stools (detected before enrollment) prior to enrollment.
- Participation in another 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 |
|---|---|---|
| Partially Hydrolyzed FormulaPartially Hydrolyzed Whey Protein Infant Formula | Other | Partially Hydrolyzed Formula |
| Normal FormulaNormal Formula | Other | Normal Formula |
Primary outcome
Change of total symptom score of infant feeding & stool pattern questionnaire.
Time frame: From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).
Investigator report questionnaire. Total score consists of 6 sub scores based on different symptom scaleing : diarrhea(0= no; 1= yes), constipation(0= no; 1= yes), galactorrhea/spit milk(0= no; 1= yes), Irritability or crying(0= no; 0.5= yes), bloating/ tummy drum/ exhaust(0= no; 1= yes), other(0= no, 0.5=yes).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Partially Hydrolyzed Formula and Normal Formula in people with Functional Gastrointestinal Disorders, run by Children's Hospital of Fudan University.
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 5 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: withdrawn, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change of total symptom score of infant feeding & stool pattern questionnaire. (time frame: From enrollment to end of treatment（1 week）. The scores will be measured at the following time point: enrollment,end of treatment(one week after the start of treatment).). 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 12 Jul 2018.