A randomized, double-blind, placebo-controlled clinical trial of nutraceutical formulation in improving gut health in adults.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1. Assessing Gut health using a Gastrointestinal Symptom Rating Scale GSRS score.
研究概览
简要总结
Gut health plays a critical role in overall well-being, influencing digestion, immunity, metabolism, and even mental health. However, imbalances in gut microbiota, inflammation, and digestive disorders are common, and current treatments may be insufficient or have unwanted side effects. Nutraceuticals, which consist of bioactive compounds from food sources, have shown potential to improve gut health by promoting a balanced gut microbiome, enhancing nutrient absorption, and reducing gastrointestinal discomfort. Preclinical and limited clinical studies have suggested that specific formulations of nutraceuticals may offer protective and therapeutic benefits to gut health.
By using a placebo control and a double-blind design, this trial aims to provide robust data on the true efficacy of these formulations. If successful, these nutraceuticals could offer a natural, side-effect-free alternative for individuals seeking to improve gut health, with broader implications for managing gut-related conditions and improving general wellness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Males and females aged 20-50years, with an equal gender distribution (both inclusive); 2.Participants must report one or more gut health-related symptoms, indicated by a GSRS score of 3 to 5 or a BSFS score of 1 to
- •Eligible symptoms include:•Bloating•Abdominal discomfort or pain•Infrequent bowel movements fewer than three defecations per week•Hard or lumpy stools types 1 to 3 on the Bristol Stool Form Scale•Sensation of incomplete evacuation during defecation.3.Participants in whom loose stools are rarely present without the use of laxatives;4.Participants on stable medication for the past three months with no worsening of symptoms or hospitalization are eligible, or may be enrolled at the discretion of the investigator;5.Participants should agree to undergo Liver Function Tests and C-reactive protein assessments;6.Willingness to undergo baseline and follow-up assessments of gut health using the GSRS;7.Participants providing voluntary, written informed consent to participate in the study.
排除标准
- •1.Participants with a diagnosis of colonic inertia; 2.Participants with a history of surgical interventions within the last six months; 3.History of anorectal surgery; 4.Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), or chronic diarrhea; 5.Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture; 6.Participants with untreated or uncontrolled systemic conditions, including HIV, diabetes mellitus, or tuberculosis; 7.Participants with renal or liver dysfunction; 8.Participants with neurological disorders, such as Parkinsons disease or multiple sclerosis; 9.A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status; 10.Participants currently using laxatives, antacids, proton pump inhibitors, antibiotics, or other probiotic products; 11.Participants using herbal supplements, dietary fiber, or phytonutrient supplements; 12.Participants will be excluded if they have initiated new micronutrient supplements e.g. iron, zinc within the past 14 days; 13.Participants who have undergone colonic cleansing in the last three months; 14.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study; 15.Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1 or 2 pack per day; 16.Any other clinical condition in the investigators judgment finds the study participation unsuitable for the participant.
结局指标
主要结局
1. Assessing Gut health using a Gastrointestinal Symptom Rating Scale GSRS score.
时间窗: 1. At screening, day 30 and day 60. | 2. From baseline to end of the study. | 3. From baseline to end of the study. | 4. At baseline and end of the study. | 5. From baseline to end of the study.
2. Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI SYM Assessment of symptoms such as heartburn, nausea, and bloating.
时间窗: 1. At screening, day 30 and day 60. | 2. From baseline to end of the study. | 3. From baseline to end of the study. | 4. At baseline and end of the study. | 5. From baseline to end of the study.
3. Changes in body weight.
时间窗: 1. At screening, day 30 and day 60. | 2. From baseline to end of the study. | 3. From baseline to end of the study. | 4. At baseline and end of the study. | 5. From baseline to end of the study.
4. Gastrointestinal Quality of Life Index GIQLI Measurement of the impact of digestive symptoms on overall quality of life, including energy, fatigue, and well being will be measured
时间窗: 1. At screening, day 30 and day 60. | 2. From baseline to end of the study. | 3. From baseline to end of the study. | 4. At baseline and end of the study. | 5. From baseline to end of the study.
5. Stool Consistency and Frequency: Bristol Stool Form Scale BSFS Evaluating stool consistency. Frequency of Bowel Movements Self reported daily bowel movements recorded using a bowel diary.
时间窗: 1. At screening, day 30 and day 60. | 2. From baseline to end of the study. | 3. From baseline to end of the study. | 4. At baseline and end of the study. | 5. From baseline to end of the study.
次要结局
- 1. Assessment of adverse events(2. Assessment of treatment compliance and tolerability of investigational products.)
研究者
Dr Ramshyam Agarwal
Lokmanya Medical Research Centre and Hospital