Thickened Feeds for Swallowing Disorders

Overseen by Daniel R Duncan, MD, MPH

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Children's Hospital

Disqualifiers: Seizure disorders, Congenital heart disease, others

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on feeding and swallowing, so it's best to ask the trial coordinators for more details.

What data supports the effectiveness of the treatment Thickened Feeds for Swallowing Disorders?

Research shows that thickened liquids can help certain patients with swallowing difficulties by reducing the risk of aspiration (when food or liquid goes into the airway). In one study, patients who had trouble swallowing thin liquids but not purees successfully used nectar-like and honey-like thickened liquids, which helped them swallow safely. ^{1 2 3 4 5}

Is it safe to use thickened feeds for swallowing disorders?

Thickened feeds are commonly used to help people with swallowing problems, but they can have risks and should be used carefully. Some studies suggest that gum-based thickeners might be safer than starch-based ones, but more research is needed to confirm this. ^{3 6 7 8 9}

How does the treatment Thickened Feeds differ from other treatments for swallowing disorders?

Thickened Feeds are unique because they modify the texture of liquids to make them easier to swallow, which can help prevent choking and aspiration (when food or liquid enters the airway). Unlike medications or surgical interventions, this treatment focuses on altering the physical properties of the food or drink itself to aid in safe swallowing. ^{10 11 12 13 14}

Research Team

Daniel R Duncan, MD, MPH

Principal Investigator

Boston Children's Hospital

Rachel Rosen, MD, MPH

Principal Investigator

Boston Children's Hospital

Sudarshan Jadcherla, MD

Principal Investigator

Nationwide Children's Hospital

Taher Omari, PhD

Principal Investigator

Flinders University

Samuel Nurko, MD, MPH

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am 21 years old or younger.

I was admitted to Boston Children's Hospital for a first-time BRUE or because I have trouble swallowing.

I have had or may have a swallow study with video.

Exclusion Criteria

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

My child is fed only through a feeding tube.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying liquid viscosities to assess effects on swallow physiology

30 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Thickened Feeds (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Slightly thick liquid swallows Experimental Treatment 1 Intervention

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

Group II: Moderately thick liquid swallows Experimental Treatment 1 Intervention

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

Group III: Mildly thick liquid swallows Experimental Treatment 1 Intervention

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

Group IV: Thin liquid swallows Placebo Group 1 Intervention

Thin liquid swallows of formula or breastmilk or other liquid

Thickened Feeds is already approved in Canada for the following indications:

Approved in Canada as Thickeners for:

• Dysphagia
• Swallowing disorders

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Dr. Kevin B. Churchwell

Boston Children's Hospital

Chief Executive Officer since 2021

MD from Vanderbilt Medical School

Dr. Sarah Pitts

Boston Children's Hospital

Chief Medical Officer since 2019

MD from Harvard Medical School

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Executive Officer since 2007

MD, M.A.C.P.

Dr. Griffin P. Rodgers

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Chief Medical Officer since 2007

MD, M.A.C.P.

Findings from Research

In a study of 84 dysphagic patients who could swallow purees safely but aspirated thin liquids, both nectar-like and honey-like thickened liquids were successfully ingested without aspiration, indicating their effectiveness for safe swallowing.

Nectar-like thickened liquids are recommended as they are effective for safe swallowing and are preferred by patients, which may improve compliance and help maintain hydration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting safe swallowing when puree is swallowed without aspiration but thin liquid is aspirated: nectar is enough. Leder, SB., Judson, BL., Sliwinski, E., et al.[2021]

Only 17% of Australian health care facilities routinely monitor the consumption of thickened fluids for clients with dysphagia, despite 51% of healthcare professionals believing that these clients do not drink enough.

Institutional factors, such as inadequate staff assistance and inconsistent monitoring systems, significantly impact fluid intake and hydration, highlighting the need for better education and clinical pathways to prevent dehydration in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of thickened fluid prescribing and monitoring practices of Australian health professionals. Murray, J., Doeltgen, S., Miller, M., et al.[2014]

A systematic review of three randomized control trials found no convincing evidence that thickening agents for liquids or texture-modified diets improve survival, quality of life, or nutritional status in individuals with oropharyngeal dysphagia.

The updated clinical guideline maintains a weak recommendation against the use of thickening agents for liquids, highlighting the need for further research to better understand their effects on aspiration risk and pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second update of a systematic review and evidence-based recommendations on texture modified foods and thickened liquids for adults (above 17 years) with oropharyngeal dysphagia. Hansen, T., Beck, AM., Kjaersgaard, A., et al.[2023]

The analysis of seven commercial thickeners for patients with dysphagia revealed significant differences in their composition and viscosity, indicating that not all products are equally effective for ensuring safe oral feeding.

Many products lacked clear preparation instructions and nutritional information, and there was no consistent correlation between viscosity classifications from the National Dysphagia Diet and the International Dysphagia Diet Standardization Initiative (IDDSI), which could lead to confusion in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lack of Standardization in Commercial Thickeners Used in the Management of Dysphagia. Machado, AS., Lenz, D., de Souza, RDS., et al.[2020]

This study tested 14 combinations of infant formulas and thickeners, conducting 1,353 IDDSI Flow Tests to determine the best recipes for achieving a stable Level 1 (slightly thick) consistency for infants with dysphagia.

Formulas thickened with Supercol® achieved a more stable consistency by 10 minutes, while those thickened with Aptamil Feed Thickener® stabilized by 15 minutes, highlighting the importance of thickener choice in managing feeding safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing and Development of Slightly Thick Infant Formula Recipes for Dysphagia Management: An Australian Perspective. Marshall, J., Buttsworth, J., Grandt, HDS., et al.[2023]

In a study of 50 children with oropharyngeal dysphagia, a systematic weaning process (SWP) allowed 78% of participants to successfully transition from thickened fluids to a thin-fluid diet, demonstrating its efficacy in managing dysphagia.

The SWP was found to be safe, with only 5% of successfully weaned patients developing pneumonia, indicating that gradual reduction of thickener can minimize risks associated with aspiration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Process for Weaning Children With Aspiration From Thickened Fluids. Wolter, NE., Hernandez, K., Irace, AL., et al.[2022]

Feeding crumbles instead of mash significantly improved growth performance in brown-egg laying pullets, increasing average daily feed intake (ADFI) and average daily gain (ADG), while also enhancing feed conversion ratio (FCR).

Higher energy content in the diet improved feed conversion ratio (FCR) but did not affect gastrointestinal tract (GIT) development, suggesting that while crumbles boost performance, they may negatively impact GIT organ weight, potentially affecting future egg production.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feed form and energy concentration of the diet affect growth performance and digestive tract traits of brown-egg laying pullets from hatching to 17 weeks of age. Saldaña, B., Guzmán, P., Cámara, L., et al.[2020]

The study examined six different batches of wheat distillers' dried grains with solubles (DDGS) from the same manufacturer and found significant variability in their nutritional value, particularly in terms of apparent metabolizable energy and growth performance in broilers.

Enzyme supplementation in the diets improved key nutritional metrics such as energy retention and fat digestibility, indicating that adding enzymes can enhance the feeding value of variable DDGS in poultry diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrient availability of different batches of wheat distillers dried grains with solubles with and without exogenous enzymes for broiler chickens. Whiting, IM., Pirgozliev, V., Rose, SP., et al.[2020]

Hydro-thermal processing methods (HTPM) like pelleting and expanding significantly improve starch digestibility in broiler feed, which can enhance overall feed efficiency and nutrient absorption.

While pelleted feeds reduce feed wastage and improve daily feed intake, they also increase the risk of proventricular dilatation, highlighting a trade-off between feed efficiency and potential digestive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Feed Particle Size and Hydro-Thermal Processing Methods on Starch Modification, Nutrient Digestibility and the Performance and the Gastrointestinal Tract of Broilers. Liermann, W., Bochnia, M., Berk, A., et al.[2020]

In two trials, pullets showed a significantly lower feed intake when offered pellets compared to mash, particularly influenced by the type of beak trimming they had received.

Pullets with trimmed beaks (either top beak or both beaks trimmed) were less likely to consume pellet feed, suggesting that beak trimming affects their feeding behavior and preferences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of beak trimming on body weight and feed intake of egg-type pullets fed pellets or mash. Deaton, JW., Lott, BD., Branton, SL., et al.[2020]

In a study involving 210 one-day-old male broilers, it was found that feeding a coarse diet significantly improved feed intake, body weight gain, and feed conversion ratio, regardless of the digestibility of the protein source used in the diet.

Increasing the level of poorly digestible protein from rapeseed meal negatively impacted gut health, as indicated by reduced villus heights and increased crypt depths, but coarse diets mitigated these effects and reduced harmful fermentation in the hindgut.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protein source and dietary structure influence growth performance, gut morphology, and hindgut fermentation characteristics in broilers. Qaisrani, SN., Moquet, PC., van Krimpen, MM., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Promoting safe swallowing when puree is swallowed without aspiration but thin liquid is aspirated: nectar is enough. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A survey of thickened fluid prescribing and monitoring practices of Australian health professionals. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Thickened liquids: do they still have a place in the dysphagia toolkit? [2021]

4. England pubmed.ncbi.nlm.nih.gov

Second update of a systematic review and evidence-based recommendations on texture modified foods and thickened liquids for adults (above 17 years) with oropharyngeal dysphagia. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Thickened liquids: practice patterns of speech-language pathologists. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Lack of Standardization in Commercial Thickeners Used in the Management of Dysphagia. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Review of the effect of amylase-resistant dysphagia products on swallowing safety. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Testing and Development of Slightly Thick Infant Formula Recipes for Dysphagia Management: An Australian Perspective. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A Systematic Process for Weaning Children With Aspiration From Thickened Fluids. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Feed form and energy concentration of the diet affect growth performance and digestive tract traits of brown-egg laying pullets from hatching to 17 weeks of age. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Nutrient availability of different batches of wheat distillers dried grains with solubles with and without exogenous enzymes for broiler chickens. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Feed Particle Size and Hydro-Thermal Processing Methods on Starch Modification, Nutrient Digestibility and the Performance and the Gastrointestinal Tract of Broilers. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Effect of beak trimming on body weight and feed intake of egg-type pullets fed pellets or mash. [2020]

14. England pubmed.ncbi.nlm.nih.gov

Protein source and dietary structure influence growth performance, gut morphology, and hindgut fermentation characteristics in broilers. [2022]