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临床试验/NCT04695340
NCT04695340撤回不适用

Effect of Psyllium (Plantago Ovata) on Digestive Disorders in Familial Amyloidosis

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家开始时间: 2023年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Effect of Psyllium administration on digestive quality of life in familial amyloidosis patients

研究概览

简要总结

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 transthyretin, resulting in a modification of the translated protein. This abnormal protein and its derivatives are deposited in the form of a toxic "amyloid" substance in tissues and organs, altering their functions, particularly in the gastrointestinal tract.

From a gastrointestinal perspective, different treatments can be proposed in the absence of specific recommendations for familial amyloidosis. The hygienic and dietary measures consist of avoiding tobacco, alcohol and carbonated drinks, limiting fatty meals rich in poorly digestible fibers, and splitting meals. If this fails, metoclopramide and domperidone are suggested. As a second-line erythromycin, can be used with caution because of cardiac risks and drug interactions. Polyethylene glycol-based osmotic laxatives can be used to treat constipation. Alternating diarrhea and constipation can be treated with ispaghul-based laxatives, aiming at transit regulation. Finally, refractory diarrhea can be treated with the administration of loperamide. If this fails, treatment with a somatostatin analogue may be offered.

However, all these treatments can present significant side effects, therefore natural alternatives are often sought. Psyllium in particular regulates transit by normalizing stool consistency: it is effective against digestive disorders such as constipation, but it is also effective in the event of diarrhea. It allows the formation of a viscous gel by the hydrophilicity of polysaccharides macromolecules, increasing the fecal bowl which stimulates peristalsis and facilitates defecation. The WHO has recognized that Psyllium is superior to wheat bran in the treatment of irritable bowel syndrome.

The main objective of the study is to assess the effect of daily Psyllium administration on digestive quality of life in familial amyloidosis patients who suffer from digestive disorders.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Effect of Psyllium administration on digestive quality of life in familial amyloidosis patients

时间窗: 6 months

The effect of Psyllium administration on digestive quality of life in familial amyloidosis patients will be evaluated at 6 months using the Gastrointestinal Quality of Life index (GIQLI)

次要结局

  • Effect of Psyllium administration on global quality of life in familial amyloidosis patients(6 months)
  • Effect of Psyllium administration on motor function in familial amyloidosis patients(6 months)
  • Effect of Psyllium administration on gastro intestinal pain in familial amyloidosis patients(6 months)
  • Effect of Psyllium administration on stool density in familial amyloidosis patients(6 months)
  • Adverse effects of Psyllium administration in familial amyloidosis patients(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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