Low FODMAP Diet for Hepatobiliary Disorders

Phase-Based Estimates
1
Effectiveness
1
Safety
Children's Nutrition Research Center, Houston, TX
Hepatobiliary Disorders+13 More
Low FODMAP Diet - Other
Eligibility
< 18
All Sexes
Eligible conditions
Hepatobiliary Disorders

Study Summary

This study is evaluating whether a diet or a specific type of therapy may be more effective for children with irritable bowel syndrome.

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Eligible Conditions

  • Hepatobiliary Disorders
  • Digestive System Diseases
  • Syndrome
  • Intestinal Diseases
  • Colicky Pain
  • Irritable Bowel Syndrome
  • Pain Disorder
  • Disease
  • Chronic Pain
  • Cholera Infantum
  • Functional Abdominal Pain
  • Functional Bowel Disorder
  • Abdominal Pain
  • Functional Gastrointestinal Disorders (FGID)
  • Somatoform Disorders
  • Functional Abdominal Pain Syndrome
  • Functional Abdominal Pain Disorders
  • Gastrointestinal Diseases

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Low FODMAP Diet will improve 1 secondary outcome and 1 other outcome in patients with Hepatobiliary Disorders. Measurement will happen over the course of 3 to 4 weeks.

3 to 4 weeks
Improvement in quality of life
6 months
Symptom Improvement

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

No Control Group
Low FODMAP diet

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. Low FODMAP Diet is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Low FODMAP diet
Other
Low FODMAP diet
Cognitive Behavioral Therapy
Other
Cognitive Behavioral Therapy

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months for reporting.

Who is running the study

Principal Investigator
R. S. M.
Prof. Robert Shulman M.D., Professor
Baylor College of Medicine

Closest Location

Children's Nutrition Research Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A child 7-12 years of age with a FGID will be recruited if the medical evaluation reveals no organic reason for the abdominal pain and the child has abdominal pain that meets the definition of a FGID (i.e., IBS, functional abdominal pain) according to the pediatric Rome III criteria (Rome IV will be substituted when validated). Parents and children must speak and understand English because of the psychological assessment and CBT requirements.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can hepatobiliary disorders be cured?

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(1) Treatment of acute cholangitis has a very good outcome, even in cases of recurrent cholangitis. (2) Treatment of alcoholic cirrhosis is more severe than that of primary biliary cirrhosis. (3) Liver regeneration is very frequent even in patients with cirrhosis. The number of patients who are capable of sustained abstinence of drinking is the same as with primary biliary cirrhosis for a short period of time and is much higher than in alcoholic cirrhoses. (4) In contrast to alcoholic cirrhoses, liver transplantation is hardly possible due to the advanced age, even though there is a good survival rate.

Unverified Answer

What is hepatobiliary disorders?

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Symptoms of gallstones and biliary tract diseases like jaundice can be easily mistaken for those of lung cancer. This underscores the importance of proper clinical examination of lung cancer in patients with these other common respiratory diseases.

Unverified Answer

What causes hepatobiliary disorders?

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The main causes of hepatic diseases including cirrhosis, fibrosis/cirrhosis, steatosis and hepatitis, respectively, are hereditary factors, alcohol and certain drugs as well as viral infections. It is also not surprising that the other nontumor types of liver diseases including fatty liver, fatty liver diseases, hepatic adenoma/carcinoma, hepatocellular carcinoma, liver abscess, cholecystitis, and cholelithiasis occur from the same causes as they all may be characterized by a steatotic change of liver cells, the hepatic inflammation and necrosis, and accumulation of fatty components in the liver, all of which are the main pathological causes of liver diseases.

Unverified Answer

What are the signs of hepatobiliary disorders?

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Signs of hepatobiliary disorders are often nonspecific and not necessarily associated with cirrhosis and its complications. Specific signs include fatigue, liver pains and jaundice. Diagnosis of hepatobiliary disorders is made by integrating signs and symptoms.

Unverified Answer

What are common treatments for hepatobiliary disorders?

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Different treatments are used to control hepatobiliary disorders. Surgical intervention is preferred to non-interventional therapy because it delivers a cure rate of 100-100%; moreover, non-interventional therapies are commonly applied to treat other hepatic disorders, such as alcoholism.

Unverified Answer

How many people get hepatobiliary disorders a year in the United States?

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About 13.5 million people get a liver disorder at least once in a year, and about 6.3 million of those who get a liver disorder need therapy to treat this condition at least once a year. This is about 40 percent of all people who get a liver disorder each year. The main liver disorder leading for this group is primary sclerosing cholangitis, which is the principal cause of liver cirrhosis in the United States. Most hepatic disorders occur in people of all ages and genders.

Unverified Answer

Have there been any new discoveries for treating hepatobiliary disorders?

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[S-1, Sorafenib, I-131 treatments were all effective in curing HBV infections while [Ruxolitinib] has been shown to be effective in the management of high-risk HCC patients and it may be used as an alternative or adjunctive therapy in patients who were not candidates for curative surgery or chemotherapeutic agents in patients with inoperable HCC. New treatments for HBV and HCC patients are needed, particularly for patients with high-risk HCC.

Unverified Answer

What are the latest developments in low fodmap diet for therapeutic use?

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Low FODMAP is a dietary intervention in the treatment of functional GI disorders that appears to offer significant benefits over traditional therapies with respect to symptoms and quality of life. Data from a recent study are supported by a larger dataset of studies. Further research is crucial for better understanding how low FODMAP can alleviate the symptoms of functional GI disorders.

Unverified Answer

Is low fodmap diet safe for people?

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The diet has a positive effect on liver function tests, but no adverse effects on liver function were found. We believe that the use of the Low Fodmap diet is safe for patients.

Unverified Answer

What is the primary cause of hepatobiliary disorders?

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The biliary system and the liver are related to various different factors influencing the risk of developing hepatobiliary disorders. The primary cause of biliary diseases is chronic excessive alcoholic intake in chronic alcoholics. The liver diseases, such as hepatopathy and chronic hepatitis, can also lead to the development of hepatobiliary disorders.

Unverified Answer

Have there been other clinical trials involving low fodmap diet?

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There is no conclusive evidence for the efficacy of low fodmap diet for the improvement of the symptoms of hepato-pancreato-biliary disease. The only relevant research trial published in the scientific literature is, in fact, an uncontrolled study and does not allow the establishment of conclusions. Considering that clinical trials of low fodmap diets are still underway, the current lack of conclusions is frustrating. Further research is necessary to determine whether low fodmap can improve the symptoms and quality of life of patients with hepato-pancreato-biliary diseases.

Unverified Answer

What are the common side effects of low fodmap diet?

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Data from a recent study support low fodmap diet's ability to improve the gastrointestinal system and the liver by reducing weight and fat accumulation. In case of weight reduction the weight loss is associated with a decrease in metabolic complications, including type 2 diabetes.

Unverified Answer
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