ALS Clinical Research

Supporting ALS patients through recovery, with care.

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that destroys the motor neurons controlling voluntary muscles. As the disease advances, patients navigate significant day-to-day challenges affecting mobility, communication, nutrition, and mental health, often requiring adaptive strategies and assistive technology to maintain their quality of life.

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Study Overview

  • 5 days, up to 4 clinic visits
  • Carefully monitored safety
  • Evaluating Rifaximin + Rehydration
Sponsored by Bausch Health Americas, Inc.

About the Study

Understanding the Process

Day-to-day challenges include:

Mobility and Dexterity: Progressive muscle weakness makes walking, standing, and transferring (e.g., getting in and out of bed) difficult. Simple fine-motor tasks like turning a key, brushing teeth, or buttoning a shirt become hurdles that require adaptive devices.

Eating and Swallowing (Dysphagia): Weakness in the throat and tongue muscles makes chewing and swallowing hazardous, increasing the risk of choking. Patients must often switch to soft or pureed foods, take smaller meals, or eventually rely on feeding tubes for hydration and nutrition.Speech and Communication (Dysarthria): Weakened facial and throat muscles lead to slurred or nasal speech, eventually making verbal communication impossible. Patients rely on augmentative and alternative communication (AAC) devices, such as eye-tracking systems or text-to-speech apps, to interact with others.

Breathing Difficulties: The muscles responsible for breathing weaken over time. Patients often require breathing aids, such as non-invasive ventilation (e.g., BiPAP) at night or portable ventilators, as respiratory failure is a primary complication.

Emotional and Cognitive Impact: Because patients usually retain their mental faculties, they are acutely aware of their physical decline. This loss of independence often leads to anxiety, depression, and significant emotional strain. Additionally, some patients experience pseudobulbar affect (uncontrollable, involuntary laughing or crying).

Fatigue and Muscle Spasticity: Persistent tiredness is a common symptom, along with tight, stiff muscles and painful cramps.Managing these evolving obstacles typically requires a robust, multidisciplinary care team, including occupational and physical therapists, dietitians, and speech-language p

What to Expect

  • Take the study medication along with standard oral rehydration therapy for 3 days.
  • Attend up to 4 brief clinic visits over a 5-day period, followed by 4 check-in phone calls.
  • Provide small blood and stool samples to help our team monitor health and progress.
  • Keep a simple daily diary of symptoms to help us understand the pace of recovery.

Who is this study for?
This study is for patients affected with ALS.

A Patient with ALS

  • Are between 6 and 11 years of age and weigh at least 33 lbs.
  • Have experienced diarrhea for less than 4 days (at least 3 loose stools within 24 hours).
  • Have or recently had a mild fever (between 100.4°F and 102.2°F).
  • Are able to attend clinic visits and provide samples with your careful consent.

This study may not be a fit if they:

  • Have taken antibiotics or certain other medications recently.
  • Are experiencing severe dehydration that requires intravenous (IV) fluids.
  • Have a history of chronic gastrointestinal conditions.
  • Are currently participating in another clinical research study.

Not sure if your child qualifies?

Take our quick eligibility quiz

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What this study provides

Your child's comfort and health are our primary focus. We have designed this process to provide close attention and care while contributing to pediatric research.

Attentive Monitoring

Your child will receive close, careful attention from our dedicated medical team, including vital sign checks and regular follow-up calls to gently monitor their well-being throughout the five days.

Study Medication

Participants will be provided with the study medication, Rifaximin, along with standard oral rehydration therapy. All study-related treatments and evaluations are provided at no cost to your family.

Meaningful Contribution

By participating, your family helps researchers understand how this medication works in children, potentially improving how we care for and treat acute diarrhea in the future.

Common questions

We understand that considering a clinical study for your child involves careful thought. Here is what other parents often ask as they begin this process.

What is a clinical trial and is it safe?

A clinical trial is a carefully monitored research study designed to understand how well a medical approach works. Your child's safety is our absolute priority. This study is overseen by medical professionals and an independent review board to ensure strict safety standards are met at every single step of the journey.

How long will my child be in the study?

The active study period is designed to be brief and unhurried. It involves taking the medication or receiving standard care for 3 days, attending up to 4 clinic visits over 5 days, and receiving 4 gentle follow-up phone calls so we can check on their progress.

What are the possible risks and side effects?

As with any medication, there is a possibility of side effects. During your initial consultation, the study doctor will sit down with you to go over all known risks in detail. We closely monitor your child throughout the study, checking vital signs and conducting tests to ensure their ongoing well-being.

Will our information be kept confidential?

Yes, completely. We treat your family's privacy with the utmost respect and care. All personal and medical information is kept strictly confidential, stored securely, and handled in full compliance with healthcare privacy laws.

Can we leave the study if we change our minds?

Absolutely. Participation is entirely voluntary. You or your child can choose to step away from the study at any time, for any reason. This decision will never affect the standard of care your child receives from their regular doctors.

Will my child receive the actual medication or a placebo?

In this specific study, there is no placebo pill. Children will be assigned to receive either the study medication (rifaximin) alongside standard oral rehydration, or standard oral rehydration alone.

What happens after the study ends?

After the final follow-up call, your child's participation is complete. The study doctor will discuss the next steps for your child's ongoing health with you, ensuring a smooth transition back to your primary care provider.