Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability
研究概览
简要总结
Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.
详细描述
Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.
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
- Single (Participant)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 18 to 75
- •Diarrheal irritable bowel syndrome (IBS-D), according to the Rome IV criteria (appendix 2)
- •Francis score > 175/500 at inclusion (corresponding to moderate to severe IBS)
- •Treatments for IBS stable for >1 month
- •Affiliation to a social security system
- •Adult person having read and understood the information letter and signed the consent form
- •Woman of childbearing age having effective/very effective contraception (Cf. CTFG) (estrogen-progestins or intrauterine device or tubal ligation) for 1 month and a negative urine pregnancy test
- •Postmenopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit or biologically documented)
排除标准
- •Taking probiotics, anti-inflammatories, corticosteroids or antibiotics systemically (oral or injectable) in the month preceding the study and during the duration of the study treatment,
- •Known diagnosis of active autoimmune disease (type 1 diabetes, lupus, multiple sclerosis, thyroiditis, ankylosing spondylitis, rheumatoid arthritis or psoriasis)
- •Known allergy to glutamine,
- •Contraindication to taking glutamine, protein powder, lactulose or mannitol (including sugar-free chewing gum),
- •Use of osmotic laxatives and/or taking lactulose and/or protein supplementation (including taking glutamine) in the 4 weeks preceding the start of the study,
- •Renal insufficiency (GFR<40mL/min), hepatic insufficiency (PT<70) or known heart disease,
- •ATCD of digestive disease (celiac disease, chronic inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy),
- •Occlusive or subocclusive syndrome,
- •Digestive perforation or suspicion of perforation,
- •Abdominal pain syndrome of undetermined cause,
- •Chronic alcohol consumption (>14 units/week),
- •Pregnant or parturient or breastfeeding woman or proven absence of contraception,
- •Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship,
- •Person participating in research participating in another trial / having participated in another trial within 2 weeks,
- •History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing them from giving informed consent.
研究组 & 干预措施
Glutamine
• Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks.
干预措施: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks (Dietary Supplement)
Protifar
• Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.
干预措施: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. (Dietary Supplement)
结局指标
主要结局
Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability
时间窗: 8 weeks
the change in Francis score measured before and after glutamine or placebo supplementation for 8 weeks in patients suffering from IBS-D with increased intestinal permeability. Rated from 0 et 500, 500 is the worst case with a severe form
次要结局
未报告次要终点