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Extremely Thick - Mildly Thick - Mildly Thick - Extremely Thick for Feeding Disorders

N/A

Recruiting

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Age > 1 year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

Awards & highlights

Study Summary

This trial will compare two different types of liquid tube feeds in 40 children over a 16-week period to see which one is better tolerated.

Who is the study for?

This trial is for children over 1 year old who get more than 90% of their calories through a G-tube and have been doing so for over 6 months. The G-tube must be at least 14 French in size. They should have moderate upper GI symptoms like nausea or bloating, with a specific symptom score above 2, and not expect to change their GI-related meds during the study.Check my eligibility

What is being tested?

The study tests two types of blenderized tube feeds that are different in thickness on children with feeding disorders. Over a period of 16 weeks, each child will try both mildly thick and extremely thick feeds to see which works better for them.See study design

What are the potential side effects?

Potential side effects from the different viscosity tube feeds may include changes in GI symptoms such as increased or decreased nausea, bloating, fullness after eating (postprandial fullness), or early satiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I often feel nauseous, bloated, full quickly, and lose my appetite.

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I am older than 1 year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks of extremely vs. 8 weeks of mildly thick blends (multiple cross-over design) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Upper GI symptoms

Secondary outcome measures

GI medication use

Gastrointestinal symptoms

Health care utilization

+8 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Mildly Thick - Extremely Thick - Mildly Thick - Extremely ThickExperimental Treatment2 Interventions

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.

Group II: Mildly Thick - Extremely Thick - Extremely Thick - Mildly ThickExperimental Treatment2 Interventions

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.

Group III: Extremely Thick - Mildly Thick - Mildly Thick - Extremely ThickExperimental Treatment2 Interventions

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.

Group IV: Extremely Thick - Mildly Thick - Extremely Thick - Mildly ThickExperimental Treatment2 Interventions

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor

761 Previous Clinical Trials

5,579,890 Total Patients Enrolled

1 Trials studying Feeding Disorders

100 Patients Enrolled for Feeding Disorders

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the overall count of individuals participating in this clinical study?

"Indeed, data available on clinicaltrials.gov highlights the ongoing recruitment of participants for this investigation. The trial's initial posting was on October 12th, 2023, and its latest update occurred on February 9th, 2024. The research aims to enroll a total of forty patients from one designated location."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Indeed, the details available on clinicaltrials.gov imply that this investigation is actively pursuing participants. Initially uploaded on October 12th, 2023 and last modified on February 9th, 2024, this trial aims to enroll a total of 40 individuals from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Clinical Trial of Blenderized Tube Feeds Varying in Viscosity

Bridget Hron 2023. "Clinical Trial of Blenderized Tube Feeds Varying in Viscosity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05417958.