Enteral NutritionNCT04516213
Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG)
A study testing Enteral Formula With (PHGG) in people with Enteral Nutrition, run by Société des Produits Nestlé (SPN) at 5 sites in United States.
Trial summary
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years over a 7 day period. Read more about this study
- Who is it for?
- Ages 1 year to 4 years
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- Enteral Formula With (PHGG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- 28 Feb 2020to 1 Jun 2021
- 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 year to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Provision of signed and dated informed consent from subject and/or subject's parents or legally authorized representatives (LAR).
- Male or female, 12 to 48 months of age, inclusive.
- Subjects requiring enteral feeding for > 7 days (in hospital, long-term care facility or at home).
- Subjects receiving enteral tube-feeding (nasogastric feeding tube or percutaneous endoscopic gastrostomy [PEG] tube) to provide 90% or more of their nutritional needs at the time of study entry.
- Subject is clinically stable (i.e. absence of any significant gastrointestinal symptoms during the past 7 days), in the opinion of the investigator.
Who cannot join
- Subjects receiving partial or total parenteral nutrition (e.g. for short bowel syndrome and other causes of intestinal failure).
- Subjects with ongoing or intermittent significant gastrointestinal symptoms during the 7 days before enrollment.
- Oncology patients recovering from chemotherapy or radiotherapy for hematological malignancies or solid tumors (last treatment within 3 months of enrollment).
- Congenital immunodeficiency syndromes (SCID etc).
- Cystic fibrosis and other causes of fat malabsorption (lymphatic malformations/lymphangiectasis).
- Subjects with any clinically significant condition (e.g. severe malnutrition, congenital heart disease, etc) that, in the investigator's opinion, would preclude inclusion in the study.
Show all 9Show fewer
- Subjects at risk for poor compliance to the study protocol in the investigator's opinion.
- Currently participating in another conflicting trial or participated in an investigational trial within 30 days of enrollment.
- Known hypersensitivity to PHGG or to any other ingredients in the investigational product.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
The University of Chicago Medicine
Chicago, Illinois, 60637
Children's Center for GI and Nutrition
Hollywood, Florida, 33021
Riley Children's Hospital
Indianapolis, Indiana, 46202
The Children's Mercy Hospital
Kansas City, Missouri, 64108
University of Utah Health Care - Huntsman Cancer Institute (HCI)
Salt Lake City, Utah, 84113-1125
About this study
Official title: An Open-label, Single-arm Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years.
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years over a 7 day period.
- Conditions
- Enteral Nutrition
- Being tested
- Enteral Formula With (PHGG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral Formula With (PHGG)Other
Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)
| Study group | Role | What they receive |
|---|---|---|
| Enteral formula tube feeding | Experimental | Enterally fed children, ages 1-4, with established enteral feeding access Receives: Other: Enteral Formula With (PHGG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI Intolerance
Occurrence of gastrointestinal intolerance (yes/no)
Measured: 7 Days
Secondary outcomes (3)
Adverse Events
Frequency and nature of adverse events
Measured: 7 Days
Energy Requirements Met
The daily percentage of energy requirements
Measured: 7 Days
Change in Weight
The change in weight over a 7-day period
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 posted18 Aug 2020
- Study start28 Feb 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
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 Enteral NutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Minor, MMS, PA-C, Principal investigator, Children's Center for GI and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516213
- Sponsor's protocol ID
- 19.02.CLI
- Status last verified
- Oct 2024
- First submitted
- 13 Aug 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Minor G, Sentongo T, Heine RG, Zemrani B. Tolerability and safety of a semi-elemental enteral formula with partially hydrolyzed guar gum (PHGG) in tube-fed children aged 1-4 years: An open-label, single-arm study. Clin Nutr ESPEN. 2023 Jun;55:392-399. doi: 10.1016/j.clnesp.2023.04.004. Epub 2023 Apr 21.
PubMed 37202073
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm Study to Evaluate the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years.
- ClinicalTrials.gov ID
- NCT04516213
- Acronym / sponsor ID
- 19.02.CLI
- Conditions
- Enteral Nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 18 Aug 2020 (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.
This is a Multicenter, Open-label, Single-arm study evaluating the Tolerance and Safety of a Peptide-based Enteral Formula with Partially Hydrolyzed Guar Gum (PHGG) in the Nutritional Management of Tube-fed Children Aged 1-4 Years over a 7 day period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enteral formula tube feeding | Experimental | Other: Enteral Formula With (PHGG)Enterally fed children, ages 1-4, with established enteral feeding access |
Who may qualify
- Ages
- 1 year to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent from subject and/or subject's parents or legally authorized representatives (LAR).
- Male or female, 12 to 48 months of age, inclusive.
- Subjects requiring enteral feeding for > 7 days (in hospital, long-term care facility or at home).
- Subjects receiving enteral tube-feeding (nasogastric feeding tube or percutaneous endoscopic gastrostomy [PEG] tube) to provide 90% or more of their nutritional needs at the time of study entry.
- Subject is clinically stable (i.e. absence of any significant gastrointestinal symptoms during the past 7 days), in the opinion of the investigator.
Key exclusion criteria (9 listed)
- Subjects receiving partial or total parenteral nutrition (e.g. for short bowel syndrome and other causes of intestinal failure).
- Subjects with ongoing or intermittent significant gastrointestinal symptoms during the 7 days before enrollment.
- Oncology patients recovering from chemotherapy or radiotherapy for hematological malignancies or solid tumors (last treatment within 3 months of enrollment).
- Congenital immunodeficiency syndromes (SCID etc).
- Cystic fibrosis and other causes of fat malabsorption (lymphatic malformations/lymphangiectasis).
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 |
|---|---|---|
| Enteral Formula With (PHGG)Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG) | Other | Enteral formula tube feeding |
Primary outcome
GI Intolerance
Time frame: 7 Days
Occurrence of gastrointestinal intolerance (yes/no)
3 secondary outcomes
Adverse Events
Time frame: 7 Days
Energy Requirements Met
Time frame: 7 Days
Change in Weight
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 15 Oct 2024.
- Derived from this study: PubMed 37202073Minor G, Sentongo T, Heine RG, Zemrani B. Tolerability and safety of a semi-elemental enteral formula with partially hydrolyzed guar gum (PHGG) in tube-fed children aged 1-4 years: An open-label, single-arm study. Clin Nutr ESPEN. 2023 Jun;55:392-399. doi: 10.1016/j.clnesp.2023.04.004. Epub 2023 Apr 21.
- Individual participant dataSharing planned: No
Related trials for Enteral Nutrition
RecruitingPhase 3
Canadian Critical Care Comparative Effectiveness Platform
Intensive Care Unit ICU, Vasopressor
Not yet recruitingObservational study
FACTORS AFFECTİNG ENTERAL FEEDİNG INTOLERANCE İN INTENSİVE CARE UNİT PATİENTS
Patients Who Receive Enteral Nutrition for at Least 72 Hours in the Intensive Care Unit Will be Included in the Study
Enrolling by invitation
Partial Enteral Nutrition as Therapeutic Augmentation of Advanced Pharmacological Therapy in Patients With Active Crohn's Disease
Crohn's Disease, Active
Not yet recruiting
Short-Term Enteral Nutrition for Infants With Bronchiolitis in Pediatric Emergency Departments
Bronchiolitis, Clinical Phenotype
Recruiting
Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants
Very Preterm Infant, Necrotizing Enterocolitis (NEC)
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.
Gerard Minor, MMS, PA-C principal investigator
Children's Center for GI and Nutrition
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enteral Formula With (PHGG) in people with Enteral Nutrition, run by Société des Produits Nestlé (SPN) at 5 sites 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 5 inclusion and 9 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
GI Intolerance (time frame: 7 Days). 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 NCT04516213, 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 15 Oct 2024.