Thickened Feeds for Swallowing Disorders

Overseen By Daniel R Duncan, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Seizure disorders, Congenital heart disease, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 30 minutes

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different liquid thicknesses affect swallowing in infants and children with dysphagia. Researchers are testing liquids thickened with rice cereal or Gelmix at mild, slight, and moderate levels, along with regular thin liquids, to determine which is safest and most effective. The trial seeks participants aged 0 to 21 years who have experienced a brief resolved unexplained event (BRUE) or have symptoms that increase their risk for swallowing issues and have had or might need a specific type of swallowing study. As an unphased trial, this study provides a unique opportunity to enhance understanding and improve treatment options for swallowing difficulties in young patients.

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 prior data suggests that thickened feeds are safe for infants and children with swallowing disorders?

Research has shown that thickened liquids, like those used in this study, have been safely used for about 19 years to assist people with swallowing problems, known as dysphagia. These liquids move more slowly than regular ones, providing more time for safe swallowing. This is crucial because it helps prevent the liquid from entering the lungs, reducing the risk of choking or infection.

For mildly and slightly thick liquids, studies indicate they are generally safe and effective in enhancing swallowing safety. They are not intended for long-term use but are used to manage swallowing issues safely.

Moderately thick liquids also improve swallowing safety. However, they might be harder to swallow for some individuals, especially if factors like dental devices are involved.

Overall, thickened liquids are commonly used to address swallowing issues in both children and adults and are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring thickened feeds for swallowing disorders because they offer a potentially safer and more effective way to manage dysphagia, especially in infants and older adults. Unlike typical treatments that often rely on medications or feeding tubes, thickened feeds adjust the consistency of liquids to make swallowing easier and reduce the risk of aspiration. This trial investigates different thickness levels using rice cereal or Gelmix, which could provide tailored options for patients depending on their specific needs. The aim is to find the optimal thickness that balances safety and ease of swallowing, opening up more personalized care strategies for those with swallowing difficulties.

What evidence suggests that thickened feeds could be effective for swallowing disorders?

This trial will compare the effects of different liquid thickness levels for children with swallowing disorders. Research has shown that thickened feeds can aid children with swallowing problems by slowing liquid flow, making swallowing easier, and preventing aspiration. Participants may receive slightly thick liquids, which studies have found to reduce the risk of liquids entering the airway in bottle-fed children with dysphagia. Others may receive mildly thick liquids, which provide similar benefits by allowing more time for safe swallowing. Moderately thick liquids, another option in this trial, can improve the coordination of sucking, swallowing, and breathing, offering better airway protection. Overall, thickened liquids can potentially reduce choking risks and make feeding safer for infants and children with these conditions. ^{5 6 7 8 9}

Who Is on the Research Team?

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

Rachel Rosen, MD, MPH

Principal Investigator

Boston Children's Hospital

Daniel R Duncan, MD, MPH

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Thickened Feeds

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Thickened Liquids for:

• Dysphagia
• Swallowing disorders

Approved in European Union as Thickened Feeds for:

• Dysphagia
• Swallowing disorders

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+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

A survey of 145 speech-language pathologists revealed that while most believe thickening liquids helps patients with swallowing difficulties, they prefer nectar-thick liquids over thicker options like honey or spoon-thick.

Despite the perceived effectiveness of thickened liquids, many patients dislike them, indicating a need for better product options and staff training to improve patient acceptance and compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thickened liquids: practice patterns of speech-language pathologists. Garcia, JM., Chambers, E., Molander, M.[2019]

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]

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]

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]

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]

There is currently no evidence that amylase-resistant thickeners improve swallowing safety compared to traditional products, as no studies directly compared them with usual care or non-amylase resistant options.

Most studies assessing amylase-resistant products relied on subjective measures of swallowing safety and did not report clinically significant outcomes like aspiration pneumonia, highlighting the need for more rigorous research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the effect of amylase-resistant dysphagia products on swallowing safety. Burnip, E., Cichero, JAY.[2023]

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]

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]

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]

Thickened liquids are commonly used to treat dysphagia, aiming to improve swallowing safety and reduce aspiration risk, but recent systematic reviews indicate that this practice lacks strong evidence and may negatively impact patients' health and quality of life.

Factors such as gaps in clinical knowledge, inadequate patient involvement, and reliance on questionable studies contribute to the continued use of thickened liquids, highlighting the need for better-informed clinical decision-making and shared decision-making with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thickened liquids: do they still have a place in the dysphagia toolkit? Lazenby-Paterson, T.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11105804/

The Effectiveness of Slightly Thick Liquids for Improving ... Conclusions: Slightly thick liquids can be effective in reducing penetration in bottle-fed children with dysphagia. However, slightly thick ...

2. withpower.com withpower.com/trial/phase-deglutition-disorders-3-2021-4da88

Thickened Feeds for Swallowing Disorders The study focuses on infants with swallowing issues and unexplained choking episodes. Thicker liquids are easier to swallow and may reduce choking risks.

3. nationwidechildrens.org nationwidechildrens.org/family-resources-education/health-wellness-and-safety-resources/helping-hands/how-and-why-to-thicken-liquids

How and Why to Thicken Liquids Thickened liquids move more slowly than thin liquids. This gives your child extra time to control the liquid while swallowing and keep it out of the lungs.

4. shaker4swallowingandfeeding.com shaker4swallowingandfeeding.com/wp-content/uploads/2021/09/Brooks_et_al-2021-Dysphagia.pdf

Thickened Liquids Using Pureed Foods for Children with ... Level 1 (slightly thick) and Level 2 (mildly thick) were the most common results (Table 2). Level 0 (thin) was recorded for 4/26 (15%) of the mixtures. Level 1 ...

5. tandfonline.com tandfonline.com/doi/full/10.1080/00325481.2025.2457318

Full article: Thickening liquids for pediatric dysphagia Thickened liquids slow the flow of liquids, allowing for improved bolus control and reducing the risk of penetration or aspiration. They also enhance the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3660277/

Thickening agents used for dysphagia management: effect on ... Thickened liquids are not a diet of choice, but one of safety, and have been used therapeutically to manage dysphagia for about 19 years [10].

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059648/

Thickened Liquids for Dysphagia Management: a Current ... Thickened liquids flow more slowly than thin liquids, and this provides extra time for a person with dysphagia to achieve airway protection during swallowing.

8. speechpathology.com speechpathology.com/articles/thickened-liquids-in-clinical-practice-20622

Thickened Liquids in Clinical Practice: The Plot “Thickens” When swallowing thick liquids, some changes occur, such as the swallow onset occurring high in the pharynx. That's probably due to the slower transit.

9. sciencedirect.com sciencedirect.com/science/article/pii/S002364382500564X

Sensory implications of thickened beverages for Dysphagia Thickeners are the primary method used to promote safe swallowing for individuals with dysphagia. A range of commercial thickeners exists ...