Status:
WITHDRAWN
Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Familial Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Familial amyloidosis is a rare disease that mainly affects the nerves and heart, but also more rarely the eyes and kidneys. This disease is due to a mutation in the gene encoding the synthesis of tran...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- male or female age ≥ 18
- suffering from familial amyloidosis confirmed by: i) the presence of a specific mutation in transthytetin gene and/or ii) amyloid deposits immunostained for transthyretin in a tissue biopsy
- stage 1 or 2 on the familial amyloid polyneuropathy scale
- receiving a stable dose for at least 3 months if treated with Patisaran® and inotersen (Tegsedi®),
- suffering from gastro intestinal pain ≥ 4 on Visual Analog Scoale (VSA)
- affiliated to social security
- able to understand the inform consent form
- if women of child bearing age, using an effective birth control method for the period of study participation
- Exclusion criteria:
- allergic to Psyllium
- intestinal or esophageal stenosis or any other type of real or suspected gastrointestinal obstruction
- protection by law under guardianship, or who cannot participate in a clinical study under Article L. 1121-16 of the French Code of Public Health
- participation in the last 3 months in a clinical research study in which he / she has been exposed to a pharmaceutical product or a medical device
- treatment with tafamidis (Vyndaqel®)
- concomitant intake of food supplements containing zinc, iron, calcium, magnesium or vitamin B12,
- contraindication to taking Psyllium, e.g. fecal impaction, gastrointestinal obstruction, esophageal or intestinal stenosis or dysphagia to liquids
- stage 0 or 3 on the familial amyloid polyneuropathy scale
- pregnant or breastfeeding female patient (a urine pregnancy test will be performed for women of childbearing age)
- any pathology or concomitant treatment that may interfere with the progress of the study.
Exclusion
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04695340
Start Date
November 1 2023
End Date
May 1 2025
Last Update
November 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital of Nice
Nice, Provence-Alpes-Côte d'Azur Region, France, 06000