Feeding DisordersNCT05417958
Clinical Trial of Blenderized Tube Feeds Varying in Viscosity
A study testing Extremely thick blenderized tube feed and Mildly thick blenderized tube feed in people with Feeding Disorders, run by Boston Children's Hospital at 1 site in United States.
Trial summary
The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Feeding Disorders
- What is being tested?
- Extremely thick blenderized tube feed and Mildly thick blenderized tube feed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- age > 1 year
- >90% of total calories via G-tube for > 6 months
- G-tube diameter ≥ 14 French
- moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score > 2
- anticipated stable GI-related medications for the duration of the study.
Who cannot join
- cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
- untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
- Nissen fundoplication
- use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
- allergy or intolerance to any component of the study diet
- inability to tolerate bolus gastric feeds.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Bridget M Hron, MD, 6173551433, bridget.hron@childrens.harvard.edu
About this study
Official title: A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
The investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.
- Conditions
- Feeding Disorders
- Being tested
- Extremely thick blenderized tube feed, Mildly thick blenderized tube feed
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extremely thick blenderized tube feedOther
Commercial blenderized tube feed, not diluted
Mildly thick blenderized tube feedOther
Commercial blenderized tube feed, diluted with ingredients contained in blend
| Study group | Role | What they receive |
|---|---|---|
| Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick | Experimental | Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. Receives: Other: Extremely thick blenderized tube feed; Other: Mildly thick blenderized tube feed |
| Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick | Experimental | Participants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. Receives: Other: Extremely thick blenderized tube feed; Other: Mildly thick blenderized tube feed |
| Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick | Experimental | Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. Receives: Other: Extremely thick blenderized tube feed; Other: Mildly thick blenderized tube feed |
| Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick | Experimental | Participants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. Receives: Other: Extremely thick blenderized tube feed; Other: Mildly thick blenderized tube feed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper GI symptoms
differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Secondary outcomes (14)
Gastrointestinal symptoms
Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Questionnaire, scale of 0 to 100, higher scores indicate less symptom burden
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Gastrointestinal symptoms
Pediatric Quality of Life Inventory Gastroparesis Questionnaire, , scale of 0 to 100, higher scores indicate less symptom burden
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Pulmonary symptoms
Pediatric Cough Questionnaire, score ranges from 0 to 25, higher scores indicate less symptom burden
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
frequency of hospital admissions
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
length of hospital admissions
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
rates of ER/urgent care visits
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
GI medication use
% of participants requiring acid suppressive medication or GI motility agents such as cyproheptadine and erythromycin
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Height
height
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Weight
Weight or weight for length
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Weight for height/body mass index (BMI)
weight for height (children < 2) or BMI (over 2 years of age)
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
number of patients with unplanned G-tube exchange
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
urine output adequacy
frequency of urine output
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
rate of respiratory suctioning per day
how often suctioning is required (e.g. number of times per day)
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
need for antibiotics for pneumonitis
frequency of antibiotics prescribed for pulmonary indications
Measured: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start12 Oct 2023
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding DisordersStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bridget Hron, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417958
- Sponsor's protocol ID
- IRB-P00042262
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2022
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel N-of-1 Randomized, Controlled, Clinical Trial to Assess the Effect of Blenderized Tube Feeds on Esophagogastric Physiology
- ClinicalTrials.gov ID
- NCT05417958
- Acronym / sponsor ID
- IRB-P00042262
- Conditions
- Feeding Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 14 Jun 2022 (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 investigators are conducting a 16 week multiple cross-over study (N-of-1 trial) comparing two blenderized tube feeds varying in viscosity in 40 children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick | Experimental | Other: Extremely thick blenderized tube feed, Other: Mildly thick blenderized tube feedParticipants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
| Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick | Experimental | Other: Extremely thick blenderized tube feed, Other: Mildly thick blenderized tube feedParticipants will receive 4 weeks Extremely Thick, 4 weeks Mildly Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
| Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick | Experimental | Other: Extremely thick blenderized tube feed, Other: Mildly thick blenderized tube feedParticipants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Extremely Thick and 4 weeks Mildly Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
| Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick | Experimental | Other: Extremely thick blenderized tube feed, Other: Mildly thick blenderized tube feedParticipants will receive 4 weeks Mildly Thick, 4 weeks Extremely Thick, 4 weeks Mildly Thick and 4 weeks Extremely Thick blenderized tube feeds. The volume, caloric density and frequency will be matched to pre-study feeding regimen. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- age > 1 year
- >90% of total calories via G-tube for > 6 months
- G-tube diameter ≥ 14 French
- moderate severity of upper GI symptoms of nausea, bloating, postprandial fullness and early satiety defined as Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) composite score > 2
- anticipated stable GI-related medications for the duration of the study.
Key exclusion criteria (6 listed)
- cystic fibrosis, primary ciliary dyskinesia, interstitial lung disease, bronchiolitis obliterans, or lung transplant
- untreated malabsorptive intestinal disease (e.g. Crohn's disease, celiac disease)
- Nissen fundoplication
- use of non-standard enteral formulas (e.g. ketogenic formulas) for the management of metabolic, endocrine or neurologic rare diseases
- allergy or intolerance to any component of the study diet
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 |
|---|---|---|
| Extremely thick blenderized tube feedCommercial blenderized tube feed, not diluted | Other | Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick, Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick, Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick, Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick |
| Mildly thick blenderized tube feedCommercial blenderized tube feed, diluted with ingredients contained in blend | Other | Extremely Thick - Mildly Thick - Extremely Thick - Mildly Thick, Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick, Mildly Thick - Extremely Thick - Extremely Thick - Mildly Thick, Mildly Thick - Extremely Thick - Mildly Thick - Extremely Thick |
Primary outcome
Upper GI symptoms
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
differences in daily parental rating of upper gastrointestinal symptoms from the validated Gastroparesis Cardinal Symptom Index-Daily Diary (GCSI-DD) between extremely and mildly thick blenderized tube feeds
14 secondary outcomes
Gastrointestinal symptoms
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Gastrointestinal symptoms
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Pulmonary symptoms
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Health care utilization
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
GI medication use
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Height
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Weight
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Weight for height/body mass index (BMI)
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
number of patients with unplanned G-tube exchange
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
urine output adequacy
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
rate of respiratory suctioning per day
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
need for antibiotics for pneumonitis
Time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extremely thick blenderized tube feed and Mildly thick blenderized tube feed in people with Feeding Disorders, run by Boston Children's Hospital 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper GI symptoms (time frame: 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)). 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 17 Apr 2026.