Single Center Clinical Trial to Evaluate the Effect of Low-dose Versus Standard-dose Iron Supplementation on the Gut Microbiome in Non-anemic Iron-deficient Females
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Microbiome diversity and oral iron therapy
研究概览
简要总结
Iron deficiency is a common problem that is often treated with the administration of oral iron.
Most of the iron is not absorbed and remains in the intestine, where it influences the balance of gut bacteria.
This influence is usually undesirable and should be kept as small as possible. With lower iron doses, the amount of unabsorbed iron is smaller and therefore a smaller change in the intestinal bacteria composition is to be expected.
详细描述
Iron deficiency affects about one in five premenopausal women. The first line treatment for patients with iron deficiency is an oral therapy with iron-supplements, another option is the intravenous iron supplementation.
The oral supplementation causes side-effects such as nausea, vomiting, abdominal pain and many more in a lot of patients. There is a positive correlation between the appearance of gastrointestinal side-effects and the applicated iron dose.
Only a low fraction of orally taken iron is actually absorbed, even in patients with iron-deficiency. Since only a fraction of the orally administered iron is actually absorbed, the toxicity of high concentrations of iron in the gastrointestinal tract and the altered selection advantages of the bacteria presumably leads to microbiome changes.
The unabsorbed iron is potentially changing the microbiome, which leads to undesirable side effects.
With low-dose iron-supplementation the amount of unabsorbed iron is smaller, therefore a dosage dependent microbiome change would be expected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Female gender
- •Premenopausal
- •Age > 18 years
- •Regular menstrual cycle
- •BMI in normal range (18-25kg/m2)
- •Serum-ferritin ≤30ng/ml
- •No anemia (hemoglobin ≥117g/l)
- •No intake of dietary supplements for at least 4 weeks
排除标准
- •Pregnancy
- •Hypermenorrhea (more than 5 unties/tampons per day)
- •Chronic inflammatory disease, psychiatric disorders
- •Hypersensitivity to iron supplements
- •chronic kidney disease (creatinine >80 µmol/l)
- •Liver disease (ALT >35 U/l)
- •Hypo- or Hyperthyroidism (TSH not between 0.16-4.25 mU/l)
- •Intake of medicines that interact with oral iron supplementation (e.g. PPI)*
结局指标
主要结局
Microbiome diversity and oral iron therapy
时间窗: 4 weeks
The microbiome is analyzed using stool samples. A stool sample is taken before and after the 4 weeks period. The low-dose arm is expected to have a smaller decrease compared to the standard-dose arm. The microbiome composition is measured using 16S rDNA gene amplicon sequencing. The results are analysed using the Shannon-Index to include diversity as well as abundance.
次要结局
- Side-effects of treatment(4 weeks)
研究者
Pierre-Alexandre Krayenbuehl
Professor Pierre-Alexandra Krayenbuehl
University of Zurich