Идёт набор NCT07094035

The Beneficial Effects on the Intestinal Function of a Food Supplement Based on an Extract of Green Tea and a Pool of Probiotics in Subjects With Irritable Bowel Syndrome With Predominance of Constipation

Без фазы С лечением IBS, Constipation Predominant

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: food supplement based on a mixture of green tea extract and a pool of probiotics., Placebo.
Кому может быть актуально: Состояния в реестре: IBS, Constipation Predominant. Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy Study of a Food Supplement Based on an Extract of Green Tea (Camellia Sinensis (L.) Kuntze - Folium) and a Pool of Probiotics (L. Plantarum, L. Rhamnosus and B. Animalis Subsp. Lactis) for the Management of Gastrointestinal Discomfort and for the Maintenance of the Balance of Intestinal Function in Subjects With Irritable Bowel Syndrome (Irritable Bowel Syndrome - IBS) With Predominance of Constipation (IBS-C): Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Trial.

Обзор

The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life. The primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.

Подробное описание

The IBS-THE-PROB25 study aims to understand whether a food supplement based on green tea and a mix of probiotics can help people suffering from Irritable Bowel Syndrome with constipation (IBS-C). The main goal is to see if this supplement improves the overall symptoms perceived by people with IBS-C.

Study participants are between 18 and 70 years old and have symptoms of IBS-C for at least 3 months, with constipation problems such as going to the bathroom less than 3 times a week and often having hard stools. There are also criteria why some people will not be able to participate, such as those who have other intestinal diseases or take certain medications.

Participants will be randomly divided into two groups. One group will take the supplement with green tea and probiotics, the other group will take a placebo (an inactive substance that looks the same as the supplements). In particular, the study plans to recruit 64 subjects (32 subjects per group), who will be randomized into the following experimental groups:

GROUP 1 (32 subjects) subjects who will have to take the food supplement, an extract of green tea (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis) GROUP 2 (32 subjects) subjects who will have to take placebo. Each subject of the two experimental groups before, during and after the administration of the dietary supplement or placebo, will undergo the evaluation of the primary and secondary outcomes. Neither participants nor doctors will know who is taking what (double-blind study). Clinicians will collect information about participants symptoms through questionnaires.

Specifically, a questionnaire called IBS-SSS will be used to assess the overall severity of symptoms. Quality of life, stool consistency (using the Bristol Scale), frequency of bowel movements, frequency and intensity of specific symptoms such as bloating and pain, use of "rescue" medications (such as laxatives) and abdominal pain will also be taken into account. A small group of participants will also need to provide stool samples to analyze substances that indicate inflammation and to see if probiotics "colonize" the gut.

The data collected will be analyzed with statistical methods to compare the two groups and see if there are significant differences in symptoms.

The trial will be conducted at a single center: COMEGEN Soc. Coop. Sociale, located in Viale Maria Bakunin, 41 (Parco S. Paolo), 80126- Naples. The Principal Investigator of the study is Dr. Matteo Laringe, also affiliated with COMEGEN Soc. Coop. Social. Subjects enrolled in the study will be followed at this location for the duration of their participation.

Вмешательства

Пищевая добавка food supplement based on a mixture of green tea extract and a pool of probiotics.
two capsules of food supplement (verum) or placebo, daily for 56 consecutive days. The daily consumption of the food supplement provides: green tea extract (Camellia sinensis (L.) Kuntze - folium) 300 mg, as a green capsule, and a pool of probiotics (Lactobacillus rhamnosus LRH020 2x10\^9 UFC, Bifidobacterium lactis BL050 2x10\^9 UFC, Lactobacillus plantarum PBS067 2x10\^9 UFC), as a white capsule.
Пищевая добавка Placebo
1 capsule/day of maltodextrin (500 mg) with a green shell, and 1 capsule/day of maltodextrin (500 mg) with a white shell for 56 days. The two colours are applied to maintain the binding.

Первичные конечные точки

Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms. [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]

Вторичные конечные точки (8)

Assessment of the impact of constipation on perceived quality of life in the last 4 weeks [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]
The effectiveness in improving stool consistency. [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]
The effectiveness of the frequency of bowel movements. [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]
The efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS. [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]
The effectiveness of the decrease in frequency in the use of salvage treatments. [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]
The efficacy against abdominal pain to be evaluated separately from intestinal discomfort. [Срок оценки: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]]
Evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin [Срок оценки: [Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)]]
Probiotic colonization rate. [Срок оценки: [Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)]]

Критерии участия

Критерии включения

aged between 18 and 70 years
able to understand and sign informed consent
HIV negative test
negative pregnancy test
With IBS symptoms for at least 3 months (with onset at least 6 months earlier)
recurrent abdominal pain at least 1 day a week, associated with two or more of the following criteria: associated with the act of defecation, associated with a change in the frequency of bowel movements, associated with a change in the shape of the stool (Rome IV diagnostic criteria)
who have less than three BM/wk and at least one of the following conditions:

in more than 25%\* of defecatory acts
lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements
feeling of incomplete evacuation in more than 25% of defecations
feeling of anorectal obstruction/blockage in more than 25% of defecations
carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations
Able to understand and comply with the requirements of the protocol.