What is the mechanism of action of this treatment?

The most common treatments for swallowing difficulty, particularly those involving liquid viscosity, include thickened liquids and modified diets. Thickened liquids work by slowing down the flow of liquids, giving patients more control over the swallowing process and reducing the risk of aspiration. This is crucial for patients with dysphagia as it helps prevent food or liquid from entering the airway, which can lead to pneumonia or other respiratory complications. By altering the thickness of liquids, these treatments improve swallow safety and efficiency, making it easier for patients to consume necessary nutrients and maintain hydration.

What side effects are associated with this type of intervention?

Common treatments for swallowing difficulty, such as altering the viscosity of liquids, can have several side effects. Patients may experience reduced compliance due to changes in texture and taste, which can affect their willingness to adhere to the modified diet. Additionally, there may be a risk of dehydration if patients reduce their fluid intake due to dislike of the thickened liquids. Proper patient education and improvements in the palatability of thickened liquids are essential to mitigate these side effects and improve compliance.

What prior FDA approvals exist?

The FDA has approved various treatments for swallowing difficulties, particularly those involving the use of thickened liquids to improve swallow safety and efficiency. These treatments often involve the use of commercial thickeners that can be added to liquids to increase their viscosity, making them easier and safer to swallow for individuals with dysphagia. Products such as xanthan gum-based thickeners and starch-based thickeners are commonly used and have been shown to reduce the risk of aspiration and improve swallowing function. These interventions are particularly relevant for patients with conditions like oropharyngeal dysphagia, where altering the thickness of liquids can significantly enhance their ability to swallow safely.

What other types of research exist?

Promising novel alternatives to varying liquid viscosity for treating swallowing difficulties include: 1) Neuromuscular Electrical Stimulation (NMES), which uses electrical impulses to stimulate muscles involved in swallowing; 2) Expiratory Muscle Strength Training (EMST), which strengthens the muscles used in breathing and swallowing; 3) Pharyngeal Electrical Stimulation (PES), which involves electrical stimulation of the pharynx to improve swallowing function; and 4) Swallowing Rehabilitation Exercises, which are targeted exercises designed to improve the strength and coordination of the swallowing muscles. These interventions have shown potential in improving swallow safety and efficiency in patients with dysphagia.

← Back to Search

Thickened Feeds for Swallowing Disorders

N/A

Recruiting

Led By Daniel R Duncan, MD, MPH

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

Age 0 to 21 years

Be younger than 65 years old

Must not have

Any nasal/pharyngeal/esophageal anomalies that might affect safe placement of the pharyngeal motility catheter

Children fed exclusively by enteral tube

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Summary

This trial will test if thickening baby formula can help infants who have trouble swallowing. The study focuses on infants with swallowing issues and unexplained choking episodes. Thicker liquids are easier to swallow and may reduce choking risks. Thicker liquids are often recommended to reduce the risk of swallowing problems.

Who is the study for?

This trial is for children aged 0 to 21 years who have swallowing difficulties, specifically those admitted to Boston Children's Hospital after a first BRUE or at risk for swallow dysfunction. It excludes kids fed only by tubes, with certain nasal/pharyngeal/esophageal anomalies, pre-existing conditions like seizures or heart disease, and allergies to specific thickeners.

What is being tested?

The study tests how different thicknesses of liquids affect the way infants and children with dysphagia swallow. Participants will try swallows of mildly thickened, thin, moderately thickened, and slightly thickened liquids while their swallow physiology is observed.

What are the potential side effects?

While not explicitly stated in the provided information, potential side effects may include discomfort from swallowing difficulties when testing various liquid viscosities and any reactions related to allergy if exposed inadvertently to allergens.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 21 years old or younger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have no issues with my nose, throat, or esophagus that could complicate catheter placement.

Select...

My child is fed only through a feeding tube.

Select...

I do not have a history of seizures or certain heart diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Swallow risk indices for thin vs mildly thick vs slightly thick liquids

Secondary study objectives

Impedance-Manometry Swallow Physiology Metrics

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Slightly thick liquid swallowsExperimental Treatment1 Intervention

Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Group II: Moderately thick liquid swallowsExperimental Treatment1 Intervention

Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Group III: Mildly thick liquid swallowsExperimental Treatment1 Intervention

Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix

Group IV: Thin liquid swallowsPlacebo Group1 Intervention

Thin liquid swallows of formula or breastmilk or other liquid

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for swallowing difficulty, particularly those involving liquid viscosity, include thickened liquids and modified diets. Thickened liquids work by slowing down the flow of liquids, giving patients more control over the swallowing process and reducing the risk of aspiration. This is crucial for patients with dysphagia as it helps prevent food or liquid from entering the airway, which can lead to pneumonia or other respiratory complications. By altering the thickness of liquids, these treatments improve swallow safety and efficiency, making it easier for patients to consume necessary nutrients and maintain hydration.