Cerebral PalsyNCT06488560
The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy (CP)
A study testing commercial blenderized tube feed (CBTF) and commercial formulas (CF) in people with Cerebral Palsy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- commercial blenderized tube feed (CBTF) and commercial formulas (CF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2024to 31 Dec 2024
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with CP receiving >75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
- Patients' insurance covers a CBTF
- Diagnosis of cerebral palsy
Who cannot join
- Receiving enteral nutrition by transpyloric feeds or jejunal tube.
- Receiving <75% of total daily energy requirements from a commercial formula
- Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart
- Rapidly progressive neurodegenerative disease diagnosis
- Use of monomeric formulas
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Fernando Navarro, MD, 713-500-5663, Fernando.Navarro@uth.tmc.edu
Ana F Alvarez, (713) 500-5663, Ana.B.FadhelAlvarez@uth.tmc.edu
About this study
Official title: The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy: A Single Center Randomized Open Label Clinical Trial
The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).
- Conditions
- Cerebral Palsy
- Being tested
- commercial blenderized tube feed (CBTF), commercial formulas (CF)
- Keywords
- Blenderized tube feeds (BTF), commercial blenderized tube feed (CBTF), Commercial formula
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercial blenderized tube feed (CBTF)Dietary supplement
Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs
commercial formulas (CF)Dietary supplement
Participant will be fed the commercial formula to meet their caloric needs per standard of care
| Study group | Role | What they receive |
|---|---|---|
| commercial blenderized tube feed (CBTF) | Experimental | Not described Receives: Dietary Supplement: commercial blenderized tube feed (CBTF) |
| commercial formulas (CF) | Active comparator | Not described Receives: Dietary Supplement: commercial formulas (CF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome.
Measured: Baseline, end of study (2 months after baseline)
Secondary outcomes (8)
Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens)
Measured: Baseline, end of study (2 months after baseline)
Change in stool metabolomic profile
Mass spectrometry will be used to assess the following metabolites: amino acids, methylated metabolites, bile acids, and nucleotides.
Measured: Baseline, end of study (2 months after baseline)
Change in salivary cytokine profile
Gene expression of the following salivary inflammatory cytokines will be assessed: interleukin-8 (IL-8), toll-like receptor 8 (TLR8), interleukin-26 (IL-26), interleukin-22 (IL-22), C-C motif chemokine receptor type 1 (CCR1), Caspase 2 (CASP2), toll-like receptor 8 (TLR8), and Intercellular adhesion molecule 3 (ICAM3).
Measured: Baseline, end of study (2 months after baseline)
Change in stool caliber using the Bristol stool scale
The Bristol stool scale categorizes stool into one of 7 types, as follows. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, and 6 and 7 indicate diarrhea.
Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)
Measured: Baseline, end of study (2 months after baseline)
Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen
Medications in the bowel regimen include antacids and laxatives.
Measured: Baseline, end of study (2 months after baseline)
Number of participants who had dose adjustments to their antacid or laxative medications
Measured: Baseline, end of study (2 months after baseline)
Change in weight
Measured: Baseline, end of study (2 months after baseline)
Change in weight percentile
Measured: Baseline, end of study (2 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Navarro, The University of Texas Health Science Center, Houston
- Investigators
- Fernando Navarro, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06488560
- Sponsor's protocol ID
- HSC-MS-24-0047
- Status last verified
- Jun 2024
- First submitted
- 7 May 2024
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Commercial Blenderized Formula on Caloric Needs, Gastrointestinal Symptoms, and Gut Microbiome in Children With Cerebral Palsy: A Single Center Randomized Open Label Clinical Trial
- ClinicalTrials.gov ID
- NCT06488560
- Acronym / sponsor ID
- HSC-MS-24-0047
- Conditions
- Cerebral Palsy
- Keywords
- Blenderized tube feeds (BTF), commercial blenderized tube feed (CBTF), Commercial formula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jul 2024 (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.
The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| commercial blenderized tube feed (CBTF) | Experimental | Dietary Supplement: commercial blenderized tube feed (CBTF) |
| commercial formulas (CF) | Active comparator | Dietary Supplement: commercial formulas (CF) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with CP receiving >75% of total daily caloric requirements from commercial formulas (CF) via a gastrostomy tube 12french or greater
- Patients' insurance covers a CBTF
- Diagnosis of cerebral palsy
Key exclusion criteria (5 listed)
- Receiving enteral nutrition by transpyloric feeds or jejunal tube.
- Receiving <75% of total daily energy requirements from a commercial formula
- Weight or weight for length or body mass index less than the 5th percentile for age or greater than the 85th% percentile for age when plotted on the cerebral palsy growth chart
- Rapidly progressive neurodegenerative disease diagnosis
- Use of monomeric formulas
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 |
|---|---|---|
| commercial blenderized tube feed (CBTF)Based on assessment by a dietician the participant will be fed the commercial blenderized formula to meet their caloric needs | Dietary supplement | commercial blenderized tube feed (CBTF) |
| commercial formulas (CF)Participant will be fed the commercial formula to meet their caloric needs per standard of care | Dietary supplement | commercial formulas (CF) |
Primary outcome
Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale.
Time frame: Baseline, end of study (2 months after baseline)
This is a 74 item questionnaire and each is scored from 0 (never) to 4 (almost always), higher score indicating worse outcome.
8 secondary outcomes
Change in fecal samples for microbiome analysis (identity, composition, and relative abundance of bacterial taxa in stool specimens)
Time frame: Baseline, end of study (2 months after baseline)
Change in stool metabolomic profile
Time frame: Baseline, end of study (2 months after baseline)
Change in salivary cytokine profile
Time frame: Baseline, end of study (2 months after baseline)
Change in stool caliber using the Bristol stool scale
Time frame: Baseline, end of study (2 months after baseline)
Number of participants who needed to add or remove antacid or laxative medications from their bowel regimen
Time frame: Baseline, end of study (2 months after baseline)
Number of participants who had dose adjustments to their antacid or laxative medications
Time frame: Baseline, end of study (2 months after baseline)
Change in weight
Time frame: Baseline, end of study (2 months after baseline)
Change in weight percentile
Time frame: Baseline, end of study (2 months after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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.
Fernando Navarro principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing commercial blenderized tube feed (CBTF) and commercial formulas (CF) in people with Cerebral Palsy, run by The University of Texas Health Science Center, Houston 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 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: status not confirmed, as of the sponsor's last update on 5 Jul 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Navarro, MD ((713) 500-5663, Fernando.Navarro@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life as assessed by the Pediatric QoL Inventory of GI Symptom Scale. (time frame: Baseline, end of study (2 months after baseline)). 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 5 Jul 2024.