A Study of Chios Mastic Water in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Chios mastic is a natural product with strong antimicrobial, anti-inflammatory and
      antioxidant properties, and well-established benefits for dyspeptic disorders. The aim of the
      present study is to investigate the effectiveness of a natural aqueous extract of Chios
      mastic (mastic water), a by-product of Chios mastic processing, in the management of
      irritable bowel syndrome. This will be a 3-month randomized double-blind controlled clinical
      trial in adult patients with irritable bowel syndrome under standard medication. Participants
      will be blindly randomized to a low-dose mastic group, which will receive a carbonated water
      enriched with Chios mastic water (0.06%), a high-dose mastic group, which will receive a
      carbonated fruit juice enriched with Chios mastic water (0.55%), or one of the two control
      groups, which will receive an identical placebo water/fruit juice with no active ingredients.
      Participants will be evaluated in terms of anthropometric indices, lifestyle habits, severity
      of IBS-related gastrointestinal symptoms, quality of life, as well as biochemical,
      inflammatory and oxidative stress markers, both pre- and post-intervention.
    

Detailed description: 
      Chios mastic is the resin of the mastic tree (Pistacia Lentiscus var. Chia), produced
      exclusively in the southern part of the Greek island of Chios. References about its medical
      use from local populations for the treatment of gastrointestinal disorders or as a cosmetic
      agent can be found in ancient texts. Nowadays, this versatile resin has been rediscovered,
      not only as a traditional remedy and aromatic agent, but as a potent phytotherapeutic product
      with strong anti-inflammatory, anti-microbial and anti-oxidant properties. In 2015, Chios
      mastic was recognized as a herbal medicinal product by the European Medicines Agency (EMA),
      with two therapeutic indications: mild dyspeptic disorders and skin inflammation/healing of
      minor wounds (EMA/HMPC/46758/2015). Over the last years, Chios mastic is widely used in
      medicinal products, food supplements and cosmetics and has become the object of intense study
      in the fields of Nutrition and Pharmacotechnology.

      Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disease characterized
      by adverse changes in bowel function (frequency of bowel movements and/or stool composition)
      and abdominal pain. The clinical presentation of IBS usually includes symptoms of abdominal
      pain, flatulence, bloating, diarrhea and constipation that often alternate, while
      postprandial discomfort in the upper abdomen, feeling of fullness, nausea, vomiting and back
      pain are less commonly reported. IBS affects approximately 7-16% of the general population,
      and leads to reduced functionality and productivity and a significant deterioration in
      quality of life due to its various intestinal manifestations. The first-line pharmacological
      treatments for IBS aim at alleviating symptoms and include antispasmodics or anticonvulsants
      for abdominal pain, antidiarrheal medication and laxatives for constipation. Dietary
      modifications, such as the avoidance of foods that aggravate gastrointestinal symptoms and
      various types of exclusion diets, are also applied as adjunctive therapies for IBS
      management, but evidence of their effectiveness remains scares and inconclusive.

      The use of foods/beverages enriched with Chios mastic could constitute a promising
      complementary approach for the management of IBS, in combination with current first-line
      pharmacological treatments. The aim of the present interventional study is to explore the
      effectiveness of a natural aqueous extract of Chios mastic in the management of IBS.

      The study will be a 3-month parallel, randomized (allocation ratio 1:1), controlled,
      double-blind clinical trial in a sample of 60 adult patients with IBS. Eligible participants
      will be adult (18-65 years old) otherwise healthy individuals with an IBS diagnosis based on
      ROME IV criteria under stable medication. Participants will be excluded on the basis of the
      presence of other chronic gastrointestinal diseases, the presence of other serious
      comorbidities, or recent significant changes in lifestyle habits. Participants will be
      randomized to a low-dose mastic group (LDMG), a low-dose control group (LDCC), a high-dose
      mastic group (HDMG) or a high-dose control group (HDCC). The LDMG will be provided with 600
      mL of a sparkling water (mastiqua) containing the natural mastic aqueous extract (0.06%) to
      be consumed daily (3 bottles of 200 mL each). The HDMG will be provided with 600 mL of a
      sparkling fruit juice (mastiqua lemon) containing the natural mastic aqueous extract (0.55%)
      to be consumed daily (3 bottles of 200 mL each). The LDCC and HDCC will receive the same
      quantity of a placebo sparkling water or fruit juice, respectively. For each type of drink
      (water and fruit juice), the intervention and placebo drinks will be unlabeled and identical
      in appearance and organoleptic characteristics, including the characteristic Chios mastic
      aroma. Randomization will be performed by an investigator with no clinical involvement, while
      all patients and study team members will be blinded to patient allocation in study groups.

      All enrolled patients will continue their standard medical treatment which must remain stable
      throughout the trial. The study physician will systematically record potential side-effects
      and will be in charge of terminating the intervention if needed. Participants will be
      assessed in terms of anthropometric indices (body weight, height, waist circumference, and
      body composition), lifestyle habits (diet and physical activity habits), the presence and
      severity of gastrointestinal symptoms, and quality of life both pre- and post-intervention.
      In addition, blood samples after a 12-hour fast and morning urine samples will be collected
      to measure biochemical, inflammatory and oxidative stress markers.
    

Intervention name(s): Chios mastic water; Placebo water; Chios mastic fruit juice; Placebo fruit juice
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Participants randomized to this intervention arm will be provided with a sparkling water enriched with the natural mastic aqueous extract (0.06%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.; Participants randomized to this intervention arm will be provided with a standard sparkling water and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.; Participants randomized to this intervention arm will be provided with a sparkling fruit juice enriched with the natural mastic aqueous extract (0.55%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.; Participants randomized to this intervention arm will be provided with a standard sparkling fruit juice and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep the use of medication and dietary supplements stable and preserve their typical lifestyle habits throughout the study.
Other intervention name(s): Mastiqua; Mastiqua lemon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pistacia Lentiscus var. Chia; Chios mastic; mastiha; irritable bowel syndrome; dyspepsia; constipation; diarrhea; abdominal pain; bloating; gastrointestinal health