DysphagiaNCT05026476
Acceptability and Tolerance Study of a Thickener
An observational study of Dysphagia, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
Trial summary
This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia Read more about this study
- Who is it for?
- Ages 6 months to 10 years
- Conditions the study is for
- Dysphagia
- What is being tested?
- Resource Thicken up Junior
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Aug 2021to 1 Mar 2023
- Phase
- Observational
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Study population: infants and children
Who may be able to join
- Infants and children aged 6 months and over who require a thickener for reflux, GORD, dysphagia II. Infants and children already on a thickener for the management of reflux, GORD and dysphagia III. Parents to avoid introducing new weaning/ new foods (for the older infants) whilst on the thickener for 1 week when measuring GI tolerance and thickener intake IV. Willingly given, written, informed consent from patient or parent/guardian
Who cannot join
- Inability to comply with the study protocol, in the opinion of the investigator.
- Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Allergy to milk (thickener is made in a factory that handles milk) IV. Children under the age of 6 months of age V. Emergencies VI. Participation in another interventional study
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster Hospital Foundation Trust
London, SW10 9NH
About this study
Official title: Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance) of a Thickener
This is a prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia
Read the detailed description
To evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the submission to the Advisory Committee for Borderline Substances (ACBS).
- Conditions
- Dysphagia
- Being tested
- Resource Thicken up Junior
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resource Thicken up JuniorDietary supplement
Each infant and child will be switch over to receive for a period of 7 days (new thickener)
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal tolerance
Measure using daily diary
Measured: 7 days
Secondary outcomes (1)
Participant compliance
Daily intake using diary
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 posted30 Aug 2021
- Study start16 Aug 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Analou Sugar, Principal investigator, Chelsea and Westminster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026476
- Sponsor's protocol ID
- RJ1
- Status last verified
- Nov 2024
- First submitted
- 24 Aug 2021
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acceptability (including Gastrointestinal Tolerance, Compliance) of a Thickener
- ClinicalTrials.gov ID
- NCT05026476
- Acronym / sponsor ID
- RJ1
- Conditions
- Dysphagia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 30 Aug 2021 (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 prospective, acceptability study to evaluate the gastrointestinal tolerance and compliance of a thickener for the management of reflux, GORD and dysphagia
Detailed description
To evaluate the gastrointestinal tolerance and compliance of a thickener for 7 days for the submission to the Advisory Committee for Borderline Substances (ACBS).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants and children
Key inclusion criteria (1 listed)
- Infants and children aged 6 months and over who require a thickener for reflux, GORD, dysphagia II. Infants and children already on a thickener for the management of reflux, GORD and dysphagia III. Parents to avoid introducing new weaning/ new foods (for the older infants) whilst on the thickener for 1 week when measuring GI tolerance and thickener intake IV. Willingly given, written, informed consent from patient or parent/guardian
Key exclusion criteria (3 listed)
- Inability to comply with the study protocol, in the opinion of the investigator.
- Contraindications to any feed ingredients (see nutritional table and ingredients list) III. Allergy to milk (thickener is made in a factory that handles milk) IV. Children under the age of 6 months of age V. Emergencies VI. Participation in another interventional 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 |
|---|---|---|
| Resource Thicken up JuniorEach infant and child will be switch over to receive for a period of 7 days (new thickener) | Dietary supplement | – |
Primary outcome
Gastrointestinal tolerance
Time frame: 7 days
Measure using daily diary
1 secondary outcome
Participant compliance
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 6 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Analou Sugar principal investigator
Chelsea and Westminster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, run by Société des Produits Nestlé (SPN) at 1 site in United Kingdom.
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 1 inclusion and 3 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 Nov 2024. 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 Kingdom. 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?
Gastrointestinal tolerance (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 6 Nov 2024.