What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome, particularly IBS-D, include Eluxadoline, loperamide, and bile acid sequestrants. Eluxadoline can cause side effects such as constipation, nausea, and abdominal pain. Loperamide, used to reduce stool frequency and consistency, may lead to constipation and should be used cautiously in patients with alternating symptoms. Bile acid sequestrants, like cholestyramine, can result in bloating, flatulence, abdominal discomfort, and constipation.

What prior FDA approvals exist?

Eluxadoline, a mixed μ-opioid receptor agonist and δ-opioid receptor antagonist, has been approved by the FDA for the treatment of IBS with diarrhea (IBS-D). Other FDA-approved treatments for IBS-D include loperamide, an antidiarrheal agent that inhibits peristalsis and prolongs transit time, and bile acid sequestrants like cholestyramine, which are used for patients with bile acid malabsorption. Additionally, rifaximin, a non-absorbed oral antibiotic, is approved for IBS without constipation, particularly for patients with bloating. These treatments offer various mechanisms to manage the symptoms of IBS-D.

What other types of research exist?

Promising novel alternatives to Eluxadoline for IBS treatment include guanylate cyclase agonists like Linaclotide and Plecanatide, which stimulate intestinal fluid secretion and transit. Additionally, bile acid sequestrants such as Colesevelam may be considered for patients with IBS-D due to their ability to manage bile acid malabsorption. These alternatives have shown efficacy in clinical trials and offer different mechanisms of action that could benefit IBS patients.

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Mu-opioid Receptor Agonist

Eluxadoline for Irritable Bowel Syndrome

Phase 2

Recruiting

Research Sponsored by Allergan

Eligibility Criteria Checklist

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

Must have

Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative.

Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following: Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following: Related to defecation, A change in frequency of stool, A change in form (appearance) of stool, After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.

Must not have

Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).

Participant has a history or current diagnosis of constipation with encopresis.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (2 weeks prior to randomization) to week 4

Summary

This trial is testing a medication to help manage IBS-D symptoms in children. The goal is to see how well it works, how the body processes it, and if it is safe for kids. The study focuses on children because they need effective treatments for IBS-D. The medication is taken orally and is designed to treat diarrhoea-predominant irritable bowel syndrome.

Who is the study for?

This trial is for kids aged 6-17 with IBS-D, which means they have tummy pain and diarrhea but not constipation or other bowel diseases. They should be able to use an eDiary (or their parents can help) and mustn't have had certain surgeries or conditions like celiac disease. Girls who can have babies must test negative for pregnancy and agree to use reliable birth control.

What is being tested?

The study tests Eluxadoline, a drug meant to ease IBS-D symptoms in children, against a placebo (a pill with no active drug). It also checks how the body processes the drug and its safety. Kids will randomly get either Eluxadoline or the placebo while researchers track their symptom changes.

What are the potential side effects?

While specific side effects for children aren't listed here, Eluxadoline in adults may cause nausea, belly pain, mild constipation, and sometimes more serious issues like pancreatitis or muscle spasms. The trial will monitor kids closely for any similar reactions.

Eligibility Criteria

Inclusion Criteria

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

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I mostly have watery or mushy bowel movements without using laxatives.

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I have been diagnosed with IBS-D, experiencing abdominal pain and changes in my bowel movements.

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My average stomach pain has been mild or none in the last 2 weeks.

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I have had loose stools without using laxatives at least twice a week in the last 2 weeks.

Exclusion Criteria

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

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I do not have a gallbladder.

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I have or had constipation with accidental bowel leakage.

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I have been diagnosed with a type of IBS or functional constipation according to Rome IV criteria.

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I have or had an inflammatory or immune-related lower GI disorder, including Crohn's in the upper GI.

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I have celiac disease or a positive test for it without a biopsy ruling it out.

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I have a condition that affects my body's ability to absorb nutrients.

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I have lactose or fructose intolerance that causes diarrhea or abdominal pain.

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I had a confirmed GI infection in the last 3 months.

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I have a liver condition classified as mild, moderate, or severe.

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I have a history of severe constipation or related complications.

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I have had serious intestinal problems or surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (2 weeks prior to randomization) to week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (2 weeks prior to randomization) to week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (2 weeks prior to randomization) to week 4 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change from baseline in stool consistency averaged over the 4-week Treatment Period

Secondary study objectives

Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days

Change from baseline for daytime, nighttime, and 24 hour urgency-free days

Abdominal Pain

+2 more

Side effects data

From 2020 Phase 4 trial • 24 Patients • NCT03441581

50%

Abdominal pain

33%

Nausea

17%

Flatulence

17%

Abdominal distension

17%

Abdominal discomfort

17%

Dizziness

17%

Dry mouth

17%

Dyspepsia

17%

Diarrhoea

17%

Headache

Hot flush

Bowel movement irregularity

Anxiety

Hypothyroidism

Vomiting

Impaired fasting glucose

Muscular weakness

Constipation

Dyschezia

Dysgeusia

100%

80%

60%

40%

20%

Study treatment Arm

Eluxadoline 100 mg With BAM

Eluxadoline 100 mg Without BAM

Trial Design

4Treatment groups

Experimental Treatment

Group I: PlaceboExperimental Treatment1 Intervention

Dose-matched placebo, oral administration, twice daily

Group II: Eluxadoline 50mgExperimental Treatment1 Intervention

Eluxadoline 50mg, oral administration, twice daily

Group III: Eluxadoline 25mgExperimental Treatment1 Intervention

Eluxadoline 25mg, oral administration, twice daily

Group IV: Eluxadoline 100mgExperimental Treatment1 Intervention

Eluxadoline 100mg, oral administration, twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Eluxadoline

2018

Completed Phase 4

~3610

0 / 15Eligibility 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

Common treatments for Irritable Bowel Syndrome (IBS) work through various mechanisms to alleviate symptoms. Eluxadoline, a mixed μ-opioid receptor agonist and δ-opioid receptor antagonist, reduces bowel contractions and pain, making it effective for IBS with diarrhea (IBS-D). Loperamide, an antidiarrheal, inhibits peristalsis and prolongs transit time, reducing stool frequency and consistency. Bile acid sequestrants like cholestyramine bind bile acids, decreasing diarrhea by reducing colonic secretion and motility. Understanding these mechanisms helps IBS patients and their doctors choose the most effective treatment, tailored to their specific symptoms, thereby improving quality of life and minimizing side effects.

Impact of patient and disease characteristics on the efficacy and safety of eluxadoline for IBS-D: a subgroup analysis of phase III trials.Eluxadoline: A Review in Diarrhoea-Predominant Irritable Bowel Syndrome.New therapeutic options for IBS: the role of the first in class mixed µ- opioid receptor agonist and δ-opioid receptor antagonist (mudelta) eluxadoline.