Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2026-03-30 @ 1:52 AM
Study NCT ID:
NCT05389761
Status:
COMPLETED
Last Update Posted:
2023-03-23
First Post:
2022-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fibromyalgia Treatment With Enzyme DAO
Sponsor:
Centros de Investigación de Nutrición y Salud
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of Fibromyalgia Treatment With Enzyme DAO (Diamine-oxidase)
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Fibromyalgia is a complex and common chronic pain disorder that affects 12 million Europeans. Fibromyalgia causes persistent widespread pain in muscles, tendons, ligaments, and joints, as well as widespread tenderness to touch and the presence of extreme fatigue and weakness.
Histamine is a molecule derived from an essential amino acid, histidine. It is stored in mast cells and basophils and is excreted through the intestine, being degraded as it passes through the intestinal mucosa by the enzyme Diamine Oxidase (DAO), which is found in this area. If there is any alteration in its metabolism and normal concentrations of histamine in the blood (50-70 mg/l) are not maintained, the free circulation of this amine in high concentrations triggers undesired effects, such as migraine, fibromyalgia, asthenia and atopy.
DAO deficiency is an alteration in the metabolism of dietary histamine that occurs when there is little activity of the DAO enzyme. The low activity of the enzyme causes that a concentration considered normal of histamine from food cannot be metabolized and a transepithelial penetration of exogenous histamine occurs. In this way, histamine passes into the bloodstream, increasing its plasma concentration and once located freely in the blood, it is distributed throughout different parts of the body, producing adverse effects.
One of the factors that causes DAO deficiency is genetics. The genetic sequence of DAO is found in a fragment located on chromosome 7 (7q34-q36) of the human genome. There are 85 single nucleotide variants (SNPs) located and identified in the human DAO gene (AOC1). Seven of these SNPs produce amino acid substitution, being candidates to cause alterations in the metabolic capacity of the enzyme.
Since histamine accumulation can trigger fibromyalgia, and the enzyme DAO has been shown to degrade histamine, oral supplementation with DAO food supplements, prepared from pig kidney, is suggested as a treatment for fibromyalgia.
The objective of this study is to analyze whether DAO enzyme supplementation reduces the characteristic symptoms of fibromyalgia. In addition, the prevalence of DAO deficiency in women with fibromyalgia will be identified by genetic analysis of DAO deficiency from a saliva sample. It will also be evaluated if patients require a lower intake of analgesics after supplementation with the enzyme DAO.
Histamine is a molecule derived from an essential amino acid, histidine. It is stored in mast cells and basophils and is excreted through the intestine, being degraded as it passes through the intestinal mucosa by the enzyme Diamine Oxidase (DAO), which is found in this area. If there is any alteration in its metabolism and normal concentrations of histamine in the blood (50-70 mg/l) are not maintained, the free circulation of this amine in high concentrations triggers undesired effects, such as migraine, fibromyalgia, asthenia and atopy.
DAO deficiency is an alteration in the metabolism of dietary histamine that occurs when there is little activity of the DAO enzyme. The low activity of the enzyme causes that a concentration considered normal of histamine from food cannot be metabolized and a transepithelial penetration of exogenous histamine occurs. In this way, histamine passes into the bloodstream, increasing its plasma concentration and once located freely in the blood, it is distributed throughout different parts of the body, producing adverse effects.
One of the factors that causes DAO deficiency is genetics. The genetic sequence of DAO is found in a fragment located on chromosome 7 (7q34-q36) of the human genome. There are 85 single nucleotide variants (SNPs) located and identified in the human DAO gene (AOC1). Seven of these SNPs produce amino acid substitution, being candidates to cause alterations in the metabolic capacity of the enzyme.
Since histamine accumulation can trigger fibromyalgia, and the enzyme DAO has been shown to degrade histamine, oral supplementation with DAO food supplements, prepared from pig kidney, is suggested as a treatment for fibromyalgia.
The objective of this study is to analyze whether DAO enzyme supplementation reduces the characteristic symptoms of fibromyalgia. In addition, the prevalence of DAO deficiency in women with fibromyalgia will be identified by genetic analysis of DAO deficiency from a saliva sample. It will also be evaluated if patients require a lower intake of analgesics after supplementation with the enzyme DAO.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: